DMCG Careers

Want to join our team? Attach your resume, and we will contact you as soon as a position is available. DMCG is constantly working on new client needs. Here are some of the general client role descriptions that DMCG is currently looking to fill. If you are interested please send your MS Word (no PDF) format resume. One of our representatives will contact you as soon as possible.

Resumes to: careers@dmcginc.com

Design Engineers

Guaynabo, PR

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Design Engineers (structural, electrical, mechanical, architectural)

We are seeking contractors to support a global Construction organization located in Guaynabo, PR.

Available/Qualified contractors please provide a detailed and up to date MS Word format resume.

Requirements/Qualifications:
1) Licensed w/ active CIAPR registration
2) 5 years’ minimum experience with industrial project design
3) Bilingual (Spanish and English as base)
4) Dynamic, self-starter with leadership skills
5) Familiarized with the use of design software’s
6) Familiarized with the use of CAD & 3D software’s

Sr. Specialist QA – (29189)

Juncos, PR

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Doctorate degree in Science/Engineering and 2 years of directly related experience or Master’s degree in Sciences/Engineering and 6 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 8 years of directly related experience.

Experience in deviations and change control.

Administrative Shift

Description:
• In support of Client’s Quality Assurance program acts as the technical specialist.
• Review and approve product MP’s.
• Approve process validation protocols and reports for mfg. Processes.
• Represent Quality on incident triage team.
• Approve Environmental Characterization reports.
• Release of sanitary utility systems.
• Approve planned incidents.
• Represent QA on NPI team.
• Lead investigations.
• Own site quality program procedures.
• Designee for QA manager on local CCRB.

Doctorate degree and 2 years of directly related experience or Master’s degree and 6 years of directly related experience or Bachelor’s degree and 8 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS
Project management skills. Strong organizational skills, including ability to follow assignments through to completion. Initiate and lead cross functional teams Enhanced skills in leading, influencing, and negotiating. Strong knowledge in area of expertise. Collaborate and coordinate with higher level outside resources. Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation, and processes development. Demonstrated ability to interact with regulatory agencies. Strong word processing, presentation, database and spreadsheet application skills.

Strong communication (both written and oral), facilitation and presentation skills. Strong skill in working independently and to effectively interact with various levels. Advanced data trending and evaluation. Ability to evaluate compliance issues. Demonstrate the Client Values/Leadership Practices.

Project Manager

Tulare, CA

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Purpose of Position:

To provide highly skilled project management services for the Tulare Court beginning with the planning phase of the project, through the duration of the project, and until successful close out. The role of the consultant includes to plan, execute, monitor, control, and close the project according to defined objectives and overall project management best practices, which includes identifying needed project resources, coordinating the efforts of team members, and reporting to the court executive team in order to deliver the project on time and within budget. This includes management of project scope, schedule, budget, change control, issues and risk management.

Location: Tulare, CA

Estimated start date: December 2019

Primary Responsibilities:

• Develop, in consultation with end users, project plan, refining objectives, scope, assumptions, risks, schedule, success criteria and deliverables.
• Interface with all levels of organization to facilitate completion of project and success criteria on time, within scope and budget.
• Project schedule development, including adjustments based on the progress of work and specific recommendations for prioritizing and accelerating critical path items.
• Coordinate the execution of program deliverables for the Court, all involved justice partners and third-party vendors.
• Manage day-to-day activities of project team.
• Adhere to and successfully meet Schedule of Deliverables identified in the Pretrial Pilot Program.
• Provide both high-level and granular reporting of all deliverables, timetables and budgets.
• Manage scope control and change management activities as necessary.
• Monitor risk and advise the Court executive team.
• Manage communication within the Court executive team and justice partners.
• Collecting and organizing contracts, reports, logs, and other supporting documentation necessary for project worksheets.
• Develop and deliver periodic project status reports, presentations and related project documentation to the court executive project team.
• Coordinate stakeholder meetings and collaborative sessions.
• Schedule and document Quality Assurance testing activities.
• Identification of long-lead items to facilitate the earliest feasible date for project completion.
• Overall project management, including facilitating all phases of projects concurrently, from predesign through completion.

Minimum Qualifications:

• Education: Bachelor’s (required)
• Experience: 5+ years of project management experience in project management and client product/service delivery, implementing enterprise systems and software with at least 3 years managing large-scale and complex enterprise software projects.
• Certification: Project Management Professional (PMP) certification

Preferred Qualifications:

• Strong oral and written communication skills; strong interpersonal skills; demonstrated time management and decision-making skills.
• Familiarity with multiple programming languages and development stacks with Mean Stack (Angular, Express.js) preferred.
• Familiarity with multiple project management methodologies i.e. PMI/PMBOK or Agile Scrum. Agile Scrum is preferred.
• Familiarity with relational backend databases i.e. SQL.
• Knowledge of judicial arraignment process and court operational processes.
• The responders including a firms primary assigned professional must have credentialed bachelor’s degree (B.A. or B.S.).
• Familiarity with Azure tenant provisioning and hosting – Desirable.
• Familiarity with Web API’s and Remote API’s.
• SDLC (Software development life cycle).
o Requirement gathering and analysis.
o Feasibility study.
o Design.

Specialist QA – (29167)

Juncos, PR

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Master’s degree in Sciences and 3 years of directly related experience or Bachelor’s in Sciences degree and 5 years of directly related experience.
Preferred Educational Background in Engineering or Biotechnology with experience in Parenteral Mfg.

Preferred experience: Project Management; Process Characterization; Environmental Qualification, Process Development.
• Non-standard Work. Need to be available to work on 1st, 2nd & 3rdam

Description:

Perform one or more of the following duties and responsibilities in support of client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.

Doctorate degree or master’s degree and 3 years of directly related experience or bachelor’s degree and 5 years of directly related experience or associate degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation Ability to evaluate compliance issues, Demonstrate the client’s Values/Leadership Practices.

Laboratory Documentation Specialist (26883)

Las Piedras, PR

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Qualifications:

5+ yrs experience BS in Sciences preferred, high school required. Knowledge on Trackwise, MIDAS, cGMPs and FDA regulations, Microsoft Word, Excel, Outlook, familiar with GMP vocabulary. Knowledge on Change Management Process. Fully bilingual. Must be self-motivated and have a strong initiative to learn. Must be results oriented.

Responsibilities:

1. Generates change requests (CRs) for the Laboratory Area in Trackwise; tracks CRs until completion.
2. Manage the change from initiation through closure including tracking changes status to ensure activities are conducted in a timely manner.
3. Generate the changes in MIDAS.
4. Reach out to other site departments for support on site changes.
5. Assists in Training development, as required.

(RESUME BANK) Process Development Scientist

Puerto Rico

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BS in Engineering (preferred in Mechanical or Chemical Engineering) or Life Sciences (preferred on Biology, Chemistry, Microbiology) and 5 years of Scientific experience.
Experience in Vial or Syringe Filling, Isolator Technology, Vial or Syringe Filling Characterization, Vial or Syringe Filling Validation.

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Under general guidance of supervisor, Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Advanced scientific analysis and troubleshooting skills. Advanced laboratory work skills. Ability to motivate and/or supervise the activities of others. Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments. Must have demonstrated skills and competencies in the following areas: Verbal communication Written communication including technical writing skills, negotiation and conflict resolution Analytical problem-solving Project management Ability to be flexible and manage change. Computer literacy (Windows environment: Word, Excel, Power Point). Skills requiring the application of scientific theory. Creative skills in the design and performance of scientific experiments and interpretation of results. Strong knowledge of cGMP’s. Fully bilingual (English/Spanish).

(RESUME BANK) Sr. Computer Validation Specialist

Puerto Rico

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Qualifications:

Bachelor’s degree in engineering, computer science or related field. 5 years’ Experience with validating computer and Automation Systems in Manufacturing equipment such as Blenders, Tablet Press, Granulators, Encapsulators, Film Coaters. Technical writing skills for the creation of protocols. Team working – Work in teams to gather and analyze data and Protocol Execution, Keen attention to detail – Must be able to quickly spot when something isn’t correct and take effective action. Good communication skills – This role requires working with people from across the manufacturing process and often working with production staff to discuss projects, adherence to protocols and implementing. Excellent written communication – Documentation is essential requirement for compliance with emphasis in attention to details creating documentation. Prioritization skills – Working with project deadlines and ensuring the manufacturing process is working efficiently at every stage, must be able to prioritize workload.

Responsibilities:

SME for Generation and execution of CSV protocols. The Computer Systems Validation (CSV) position will develop and execute protocols and test scripts. This person is responsible for writing GxP computer validation and 21 CFR Part 11 and Data Integrity related documentation such as assessments, plans, URS, FRS, RTM, UATs, OQs and summary reports.

(RESUME BANK) Quality Control Scientist

Puerto Rico

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• Technical evaluation of chemical analytical methods to determine reagents / equipment to be used, assure acquisition and deployment, develop and/or revise analytical methods Quality Standards documents.
• Determine and delineate proper implementation of the analytical methods (method transfer, validation or verification). Prepare method validation protocols, determine specifications, data evaluation, and execution of final reports and assure proper laboratory deployment of the method.
• Reports / collects / evaluates laboratory data to support cleaning process implementation.
• Coordinates / delineates / conduct laboratories works in collaboration with Quality Laboratory Analysts to collect / generate the necessary data, data evaluation and prepare the corresponding reports to support conclusions and recommendations according to the tasks assigned.
• Perform other job-related tasks as required.
• Comply with all safety and environmental guidelines, procedures, training, practices, permit conditions, and internal notification of any safety and environmental events.

Education and/or Experience:

Bachelor Degree in Science with Chemistry major (preferably).
Five (5) or more years processing experiences in Quality Control or Technical Operations is preferred or equivalent combination of education and experience.
The incumbent must have experience in product introduction and transfer, developing and validating analytical methods demonstrating skills necessary to build and maintain a high-performance.
Willing to work irregular and/or extended shifts if needed.
Able to work under pressure with minimum supervision and able to meet deadlines.

Computer Knowledge/Specific Skills:

Knowledge of Good Manufacturing Practice regulations, EPA regulations, Laboratory Safety Rules, OSHA regulations, classical and modern analytical chemistry or microbiology and sophisticated instrumental techniques.
Work experience with Office (Word, Excel, PowerPoint, and Outlook).
Minitab or any other statistical application.

(RESUME BANK) Project Manager

Puerto Rico

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Doctorate degree OR Master’s degree and 2 years of Project Management experience OR Bachelor’s degree and 4 years of Project Management experience.
Supply Chain Management, Software Trackwise QMTS, Excel Intermediate/Advanced, Product Launches and Post Launch Variations.

Oversee, manage and coordinate all operational aspects of ongoing department projects impacting multiple departments. Serves as liaison between project team and department.

FUNCTIONS
1. Manage all aspects of project(s): planning, implementation, monitoring, completion, and follow-up.
2. Manage competing timelines and prioritize critical tasks. Establish and achieves project standards for work quality and quantity.
3. Assess project issues and develop solutions to meet scientific, productivity, quality and client satisfaction goals and objectives.
4. Assist in technical, financial, and organizational issues by researching issues, providing recommendations and maintaining document archives.
5. Maintain and track project budget(s).
6. Reconcile the use of resources for the projects.
7. Identify and anticipate schedule slips or changes and analyzes the costs and resource impact.
8. Implement tools, techniques and processes to provide or create information to enable informed decision making within the teams.
9. Actively participate in directing the evolution and defining the role of the project
10. Ensure the project goals and objects are well understood by the various functional areas.
11. Liaison with department staff, sub or satellite team leaders and members to obtain their continued input and feedback on the benefits, needs, and issues associated with the project.
12. Maintain the master project plan and schedule for assigned projects.
13. Recommend and develop operational or process improvements for the performance and successful functioning of the project team.
14. Provide department management with project management support on an as needed basis as well as for special projects.
15. May manage and direct the activities of project support staff
16. Conduct annual performance reviews and provides career counseling and general guidance.
17. Identify or lead focus area projects within the overall function of project management or related projects.
18. Generate periodic updates and prepare formal presentations for required forums.
19. Generate individual and more complex reports utilizing various resources.
20. Ensure project work complies with domestic (may also involve international) regulatory requirements and approved guidelines relevant to area of responsibility.
21. Ensure project work complies with practices, policies and standard operating procedures.
22. Participate in required meetings, activities, and related projects and relevant interdepartmental activities.
23. Anticipate resource needs and communicate to management sponsors.

• Other functions that may be assigned.

EDUCATION
Doctorate degree OR Master’s degree and 2 years of Project Management experience OR Bachelor’s degree and 4 years of Project Management experience.

PREFERRED QUALIFICATIONS
• Skills in handling multiple responsibilities, priorities, tasks, and projects simultaneously.
• Skills in working under time pressure, and effectively in a team matrix environment.
• Practical project management software and spreadsheet skills, proficient computer operation skills.
• Effective interactions in a team or matrixes environment.
• Good organizational skills, detail-oriented & accurate, analytical skills.
• Team player, self-starter, persistent, tactful, and persuasive.
• Effective verbal and written communication skills (writing and presentations).
• Ability to assume increasing levels of responsibility.

(RESUME BANK) QA Specialist

Puerto Rico

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• Bachelor’s degree in Life Science or Engineering and 5 years of Manufacturing or Quality in GMP regulated environment experience.
• Project management skills
• Strong organizational skills, including ability to follow assignments through to completion
• Collaborate and coordinate with higher level outside resources
• Strong knowledge of and experience with processes involved in manufacturing, QA, QC, validation and process development
• Demonstrate ability to interact with regulatory agencies
• Strong word processing, presentation, database and spreadsheet application skills
• Strong skill in working independently and to effectively interact with various levels
• Ability to evaluate compliance issues

Description:

Perform one or more of the following duties and responsibilities in support of Client’s Quality Assurance program under minimal supervision. Review and approve product MPs. Approve process validation protocols and reports for manufacturing processes. Request Quality on incident triage team. Approve Environmental Characterization reports. Release of sanitary utility systems. Approve planned incidents. Represent QA on NPI team. Lead investigations. Lead site audits. Own site quality program procedures. Designee for QA manager on local CCRB. Review Risk Assessments. Support Automation activities. Support facilities and environmental programs. Review and approve Work Orders. Review and approve EMS/BMS alarms. Approve NC investigations and CAPA records. Approve change controls. Provide lot disposition and authorize lots for shipment.

Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related experience.

COMPETENCIES/SKILLS Project management skills, Strong organizational skills, including ability to follow assignments through to completion, Initiate and lead cross functional teams, Enhanced skills in leading, influencing and negotiating, Strong knowledge in area of expertise, Collaborate and coordinate with higher level outside resources, Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development, Demonstrate ability to interact with regulatory agencies, Strong word processing, presentation, database and spreadsheet application skills, Strong communication (both written and oral), facilitation and presentation skills, Strong skill in working independently and to effectively interact with various levels, Advanced data trending and evaluation
Ability to evaluate compliance issues, Demonstrate the Client Values/Leadership Practices.

(RESUME BANK) Sr. Automation Engineer

Puerto Rico

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Qualifications:
• Bachelor’s Degree in Engineering or Computer Science Required:
• Subject Matter Expert on PLC/SCADA system code development, testing, qualification.
• Good communication skills.
• Ability to participate in and lead highly effective teams.
• Ability to become influential in his/her area demonstrated by suitable technical degrees and/or experience.
• Ability to work with all levels of business customers in a highly dynamic environment.
• Strong leadership and interpersonal skills in motivating staff and customers in the achievement of shared objectives.
• High personal integrity, credibility, and energy.
• Ability to integrate diverse initiatives across systems development groups, business and client organizations, and infrastructure areas.
• Experience and in-depth understanding of System Development Life Cycle (SDLC) and application systems development.
• Good project management experience in relation to scope, cost, and schedule control of large automation capital projects.
• A minimum of 3 years manufacturing or related experience is required.
• Experience with automation systems for pharmaceutical facilities is required.
• In-depth understanding of System Development Life Cycle (SDLC) and applications systems development is required. Preferred:
• A minimum of 10 years in automation is strongly preferred.
• Experience and accomplishments in the project management of manufacturing automation/ execution systems.
• Other information technology experience is a plus

Responsibilities:

Automation project support role for various scale manufacturing automation projects to ensure the projects are delivered of high quality. This includes following the project through multiple phases of a project life-cycle including requirements, design, testing, installation, qualification and training. It will involve working closely with the customer, technical staff, other engineering groups and the management of suppliers to ensure a successful implementation. Major Projects include automating production of key Client products in all three areas of Manufacturing.

Projects will be for Human Health Pharmaceutical facilities and employing technologies including: Supervisory Control and Data Acquisition Systems (SCADA)
•Manufacturing Execution Systems (MES)
•Process Data Management Systems
•IT Integration Services The candidate could also serve as the Automation/IT Project Manager on a small sized project, to ensure that the project is delivered within cost and on schedule. The candidate must also understand the business needs of MMD and stay abreast of new technologies to make recommendations for business improvements. Candidate should be familiar with the application of SDLC Methodology and computer validation concepts. Candidate must possess good communication skills.

(RESUME BANK) Sr. Validation Scientist

Puerto Rico

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Bachelor’s degree in Life Sciences or Engineering and 5 years of Scientific experience OR Master’s Degree in Life Sciences or Engineering and 3 years of Scientific experience.
Cleaning and/or Sterilization knowledge.

Independently provides and/or directs the technical validation engineering support of process and/or equipment upgrades, replacements, and modifications in the laboratory, manufacturing or manufacturing support environment. Able to troubleshoot systemic validation issues. Applies advanced and diverse validation engineering principles to the design and implementation of major system or process modifications and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or validation engineering projects of significant scope and complexity. Complete complex or novel assignments requiring development of new and/or improved validation engineering techniques and procedures. Develop validation engineering policies and procedures that affect multiple organizational units. Supervise, coordinate and review work of a small staff of engineers and/or technicians on an ongoing basis as well as on a project basis. Employ advanced validation engineering techniques and/or modifications of advanced techniques within area of validation engineering expertise. Apply knowledge of validation engineering principles and practices outside of area of expertise to broad variety of assignments in related fields. Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity. Work with manufacturing, process development, utilities, facilities, labs, and/or quality assurance in developing requirements and recommendations for large and/or highly complex process, system/facility modifications. Work with project managers to complete the validation responsibilities of engineering projects within schedule, budget and quality constraints. Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. Prompt and regular attendance to the workplace.