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: email@example.com
Jr. Validation Engineer
Education: Engineering Bachelor’s Degree
Experience: Must have pharmaceutical experience, 6 months to 1 year.
For: Barceloneta area.
Send Resume to: firstname.lastname@example.org
Sr Validation Scientist 27855
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.
*Other functions may be assigned
Knowledge: Advanced validation knowledge (equipment qualification, cleaning, sterilization).
Applies extensive technical validation expertise and has full knowledge of other related disciplines.
Problem Solving: Provide technical solutions to a wide range of difficult problems. Solutions are imaginative, thorough, practicable, and consistent with organization objectives.
Discretion/Latitude: Exercises considerable latitude in determining technical objectives of assignment. Completed work is reviewed from a relatively long- term perspective, for desired results.
Supervision and guidance relate largely to overall objectives, critical issues, new concepts, and policy matters.
Impact: Essential to the completion of broad programs and projects.
Decisions, recommendations and actions form the basis of site/local program schedules and personnel/fiscal resource utilization.
Leadership: Leads efforts of group of peers directly supervises staff or project resources.
Guides the successful completion of major programs and may function in a project leadership role.
May be expected to directly supervise staff or project resources.
Liaison: Represents the organization as the prime technical contact on contracts and projects. Interacts with senior external personnel on significant technical matters often requiring coordination between organizations.
Regulatory: Understands regulatory trends in industry and able to make connection between those trends and established corporate direction. Some direct experience with FDA or equivalent regulatory body.
Represents the organization as the technical expert to endorse the organization’s validation programs and practices.
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.
- In-depth knowledge of validation processes and requirements
- Interacts effectively with variety of communication and working styles
- Ability to independently determine when additional internal resources are required to solve problems
- Ability to handle multiple projects at one time
- Demonstrated Skills in the following areas:
Basic project management
Completion and follow-up
Technical expertise areas of validation engineering.
Ability to independently determine when additional external resources are required to solve problems
Ability to provide solutions to a large variety of technical problems of moderate to large complexity and scope
Problem solving skills requiring the application of scientific and engineering theory and calculations and creative skills in the development of hypotheses and approach.
Working knowledge of financial analysis tools
Ability to delegate and manage the project work of others
Demonstrated Skills in the following areas:
Negotiation, persuasion and facilitation
Project cost development
Leadership and teambuilding
Management of contractors and vendors
*Sr. Improvement & Industrial Engineer – I (Assistant) 23435*
Bachelor’s Degree in Engineering, Industrial Engineering preferred. Over (3) years’ experience working with Industrial Engineering in the pharmaceutical/medical device industry environment. Previous experience in continuous improvements projects, project management and capacity planning. General knowledge of all aspects of Supply Chain like Pharmaceutical Manufacturing, Packaging, Material Management, Engineering, Technical Operations and the Quality Operations. Bilingual (English and Spanish). Computer Literate. Strong knowledge in Microsoft Office. Knowledge in MS Access and Minitab preferred. Knowledge of Material Flow and Related Control Systems in Manufacturing Environment. Knowledge of Financial Systems, Capacity Analysis and Operation Standards. knowledge of office-based and / or production control computer systems. PMI and Lean Manufacturing / Six Sigma trained, certification preferred. SAP knowledge preferred. Experience preparing and delivering presentations at all levels of the organization.
The Senior Improvement & Industrial Engineer oversees and manages operational standards, future operations capital needs, and development of annual budget operations standards. Works closely with the Integrated Process Team (IPT), Finance, Supply Chain and Technical Operation/Support staff to develop and maintain profit plan commitments. Monitor and analyzed OEE performance, leads continuous improvements activities (i.e., Kaizen). Manages and plans strategic industrial engineering services aligned with site initiatives for all continuous improvement initiatives of the operation (change-over, capacity increase). In addition, supports the interventions of Process Scientists on the shop floor to investigate and lead problem solving exercises of atypical, complaints or process.
Major Activities and Responsibilities
- Develops of Annual Budget Operations Standards.
- Update labor and material standards for existing products for Profit Plan.
- Maintain accurate capacity information for the IPT’S.
- Provide labor and materials standards of new products/new configurations.
- Maintain and update BOMs, Routings, Work Centers as per process improvements or inefficiencies.
- Actively participates with departments on the creation and analysis of metrics directed to define opportunities for improvement, evaluation of wastes and reduction of variation opportunities.
- Recommends and implements metrics to monitor improvements in operational performance. Provides updates and quantitative evaluation of business metrics.
- Identifies, prioritizes, and sponsors improvement projects.
- Accountable for the Annual Budget for the IPT by:
- Analyzing line performance and updating line design;
- Analyzing current and future state headcount requirements;
- Reviewing volumes to determine opportunities and risks to the plan; and
- Analyzing fixed vs. variable costs and apply to the calculation of the labor and burden rate (LBR)
- Recommending Capital Projects
- Approves Developed Financial Operational Standards.
- Supports Site Finance in NPV’s and ROI’s.
- Advices IPT’S and Site Leadership on Tactical Financial and Capacity as necessary.
- Actively participate in the Tiers, Business Review Council and any other Global Forums, as required by Site Leadership.