Engineer (31795) – Juncos, PR

Requirements Education & Experience
Master’s degree in Engineer OR Bachelor’s degree in Engineer and 2 years of Engineering experience

Preferred Qualifications
Support Drug Substance operations and applicable execution of manufacturing/quality systems such as design of operations and system requirements, procedures, deviation investigations, process monitoring, training, and new product introductions. Organizes, analyzes, and presents interpretation of results for operational issues or projects.

• Routinely monitor manufacturing processes. Suggest problem resolution and provide troubleshooting guidance. Assess observations from floor operations and gather and analyze data to identify root cause and implement solutions for process improvement opportunities.
• Function as a technical expert to process or systems regarding troubleshooting operations.
• Participate in the New Product Introductions (NPI) NPI to assess requirements for documentation, materials, training, and equipment modifications. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
• Work under the direct supervision of project managers to complete design and implementation of projects within schedule and budget.
• Initiate, revise, and approve manufacturing-controlled documents in the Document Management System. Ensure all manufacturing-controlled documents reflect current operations. Serve as a document author, owner, reviewer, or data verifier, as needed.
• Actively involved in daily operations when required to meet schedules or to resolve problems.
• Perform deviations assessments and support deviation lead during the root cause, human performance evaluation, CAPA development, and closure of record within established goal.
• Execute action owner responsibilities for CAPA records.
• Monitor effectiveness of CAPA implemented to prevent recurrence of deviation. Communicate and take additional actions, as required.

PREFERRED QUALIFICATIONS
• Education background in Engineer
• Experience in the development and/or manufacturing of bioprocesses
• Working knowledge of pharmaceutical/biotech processes
• Skilled in performance of GMP production operations
• Regulatory knowledge and interactions
• Organizational, technical writing and presentation skills.
• Project management skills
• Knowledge of control charting and basic statistics

Description:
Client requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment. In accordance with applicable law, client will provide reasonable accommodations to staff augmentation external workers who qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship to client, its operations, or its staff.

SUMMARY
Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Organizes, analyzes, and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

FUNCTIONS
1. Provide solutions to a variety of technical problems of moderate scope and complexity.
2. Under general supervision will evaluate, select and apply standard engineering techniques and procedures. Assistance given for unusual problems.
3. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. (*)
4. Initiate and complete routine technical tasks.

Operations Engineering:
1. Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems. (*)
2. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. (*)
3. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications. (*)

Design Engineering:
1. Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints. (*)
2. Work with consultants, architects, and engineering firms on development of standard design documents. (*)
3. Obtain and critique quotes for equipment modifications or installations.
4. Generate rudimentary project cost estimates and schedules.
* Other functions may be assigned

EDUCATION
Master’s degree OR Bachelor’s degree in Engineering & 2 years of Engineering experience

PREFERRED QUALIFICATIONS
• Working knowledge of pharmaceutical/biotech processes
• Familiarity with validation processes
• Familiarity with documentation in a highly regulated environment
• Ability to operate specialized laboratory equipment and computers as appropriate.
• Ability to interpret and apply GLPs and GMPs.
• Ability to apply engineering science to production.
• Able to develop solutions to routine technical problems of limited scope

Demonstrated skills in the following areas:
• Problem solving and applied engineering
• Basic technical report writing
• Verbal communication
• Comprehensive understanding of validation protocol execution requirements

Demonstrated Skills in the following areas:
• Basic technical presentations
• Personal Organization
• Validation Protocol Writing
• Dealing with and managing change
• Technical (Equipment Specific)
• Analytical Problem Solving
• Computer Literacy

ADMINISTRATIVE SHIFT