Job Description

Job Description: POSITION SUMMARY:
Reporting to the Validation Associate Director, the Analytical Validation Engineer will coordinate with the Network Quality Control Instrument Lifecycle Team, the local Quality and Microbiological Laboratories, Project Engineering and various network teams including Manufacturing Science and Technology (MST) as needed to manage the implementation and upgrades for computerized and non-computerized analytical systems and instrumentation. The Analytical Validation Scientist / Engineer will be responsible to plan, manage, and execute the start-up, commissioning, validation and qualification of new analytical instrumentation and systems, complete validation impact assessments for projects and develop and maintain validation master/project plans. The Analytical Validation Scientist / Engineer will lead and/or coach junior scientists, laboratory analysts and contractors as needed as well as provide technical expertise for project stakeholders and cross-functional teams and support network led validation projects as part of the Network QC Validation team.
Duties/Responsibilities: (describe the most critical responsibilities/accountabilities of this position)
1. Develop Computerized Laboratory Instrument Validation and Qualification documentation including, Validation Plans, User and Functional Requirement Specifications (URS/FRS), Risk Assessments, Design Qualification (DQ) Protocols, Installation and Operational Qualification Protocols (IQ/OQ), Performance Qualification (PQ) Protocols, Traceability Matrices, Configuration Specifications, and Validation Summary Reports.
2. Develop Qualification documentation for non-computerized systems.
3. Work closely with laboratory Subject Matter Experts (SME) to solve technical problems, identify worse case scenarios, and gain insight into the specific use of each instrument subject to qualification activities.
4. Support Network Quality Control (NQC) Instrument Lifecycle Team in executing network led qualification projects.
5. Drive the completion of qualification activities onsite while working with cross-functional teams.
6. Track validation project schedules and milestones.
7. Communicate progress effectively and escalate technical and logistical concerns promptly.
8. Maintain familiarity and current knowledge of Client States Pharmacopeia (USP), European Pharmacopeia (EP), Japanese Pharmacopeia (JP) for the major tests run in the QC and Microbiological Control (MC) Laboratories.
9. Support Instrument Comparability Studies with MST and laboratory qualification and implementation teams.
10. Review vendor supplied qualification protocols for technical content ensuring the protocols meet Client and Regulatory requirements.
11. Maintain safe working environment throughout the implementation and qualification process.
12. Follow company policies and procedures throughout the implementation and qualification process.
13. Operate instrumentation during installation and operational qualifications.
14. Record/review data using good documentation practices.
15. Conduct investigations as required.
16. Support Validation Services and NQC activities by writing, revising or reviewing SOPs, training materials and change requests.
17. Serve as SME during regulatory and internal inspections and ensuring timely completion of requests generated during them.
18. Maintain familiarity with Client directives and industry guidelines on validation.
19. Evaluate and assess change controls request, and make recommendation following validation services SOPs.
20. Serve as Validation Services designee as directed when training and qualifications are appropriate.
21. Support validation department activities to maintain proper documentation storage and database system.
QUALIFICATIONS
Specific Knowledge, Skills, Abilities, etc: (describe the most critical competencies which are required to perform the job)
BS degree in Engineering, Chemistry, or the Biological Sciences relevant experience or an AS degree with direct validation experience and biopharmaceutical/pharmaceutical experience. Direct experience or close familiarity with laboratory instrument qualifications is desired. Individual must have applied knowledge and understanding of regulatory requirements for lifecycle management of analytical instrumentation and computer system validation, including cGMP, 21 CFR Part 11 and Data Integrity. A working understanding of six sigma/lean principles. Excellent project management, communication, and technical writing skills are required. The Analytical Validation Engineer will possess the professionalism and technical competency required to represent the department before our customers, regulatory agencies, and management. Ability to take initiative, prioritize objectives for multiple projects, and adhere to scheduled timelines while maintaining flexibility. Contribute to a team based, collaborative and positive environment, clarity of purpose and high commitment to business goals is essential.
Education/Experience/ Licenses/Certifications: (list required education and experience, along with any additional education/experience/qualifications that are preferred)
Minimum of BS in relevant computer or scientific area with 7 years’ experience, MS degree with 4 years’ experience or PhD with limited or no experience in the biopharmaceutical industry.
Physical Demands/Work Environment: (see items to consider on last page)
This position is a primarily an office based position, however, requires routine entry into laboratories to access instrumentation which requires appropriate levels of personal protective equipment (PPE). Frequent repeated motions such as lifting, bending, twisting, squatting, walking, and reaching is required. This role also requires occasional unassisted lifting (not to exceed 50 lbs). Office-based work requires sitting. Repetitive use of arms/hands/wrists, especially when working with a computer. This position is based indoors and you will be primarily working with others, however, will also work independently and alone at times. Walking within and between buildings is required to enter laboratories and collaborate with others.
Travel: (only include if travel is required)
• This position requires up to 5% of travel
Physical Demands Considerations Work Environment Considerations:
• Unassisted lifting of items, not to exceed 50 lbs
• Bending/Stooping
• Twisting
• Crouching/Squatting
• Kneeling
• Sitting
• Crawling
• Walking-Level Surfaces
• Reaching (Shoulder)
• Repetitive (Use of Arm, Hands, Wrists)
• Grasping
• Fine Manipulation
• Use of Foot Control
• Vision (Acuity, color – correction allowed) • Office space
• Lab space
• Inside Work
• Outside Work
• Working Alone
• Working with/around others
• Chemicals
• Allergens

How to Apply

Job Types: Temporary.

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