Job Summary

In this role, you will be responsible for supporting, providing input, and leading the documentation for equipment that requires a computer system validation approach. You will collaborate with internal stakeholders (Quality Assurance (QA), Digital and Transformation (D&T), Laboratory and Metrology) to meet deliverables for commissioning integrated computer systems in a cGMP environment while reducing risk and improving compliance and productivity.

Essential Duties and Responsibilities

• Assure compliance to West Pharmaceutical Services’ Computer System Validation (CSV) program and other procedures as applicable
• Provide CSV leadership for lab systems – apply risk-based methodology to assurance/validation/qualification efforts in compliance with 21 CFR Part 11 and GAMP 5
• Ensure that the computer system validation requirements are documented to provide direction for meeting the validation needs of regulatory bodies and cGMP laboratory
• Support and/or be the liaison between D&T and the laboratory for the preparation or providing input for computer system validation documentation such as FMEA, computer system profile, URS, 21 CFR gap assessments, validation master plans, software performance qualifications, and change controls
• Collaborate with metrology, laboratory, QA and D&T, Digital Quality to maintain a state of control and compliance with established Quality Systems
• Partner with D&T to support firmware and software modifications/upgrade strategies
• Write protocols and reports directly related to CSV
• Review and approve validation life cycle documentation, including change control documents, specifications, protocols, deviations, and reports
• Utilize instrument owners’ specifications to generate and execute testing protocols for equipment following good documentation practices
• Create documentation and revisions of documents to support and maintain the quality management system for laboratory instruments
• Meet agreed to project deadlines and provide input and support to maintain the project schedules and activities for new equipment installation projects
• Keep current with the industry standard practices and Global regulatory requirements (FDA, EU) for computer systems, new technologies and cGMP regulations
• Comply with all safety practices and policies and apply required cGMP regulations
• Write and review work instructions and procedures
• Write and conduct laboratory investigations and deviations
• Other duties as assigned

LI-NJ1

LI-Hybrid

Additional Responsibilities

• Lead executive and technical parts of projects/ programs related to the implementation of new technologies.
• Guiding or technically supporting customer audits in the testing laboratory area.
• Maintains current knowledge of best practices and developments in document management technologies and techniques through participation in professional organizations or conferences, attendance at meetings or workshops, participation in educational programs, and discussions with colleagues.
• Always complies with the company’s safety and quality policies, including proper handling of biohazard materials and components.

Education

• Bachelor’s degree in a life science discipline (biology, chemistry, forensic science)

Work Experience

• Minimum 3 Years of experience in analytical metrology in cGMP laboratory
• Minimum 3 years of experience in computer system validation for analytical instrumentation and integrated computer systems
• Minimum 2 years of experience with GAMP5

Preferred Knowledge, Skills and Abilities

• 3-5 years writing, approving, executing validation protocols and reports for Analytical Instruments and Integrated Computer Systems CSV
• Minimum 5 years of experience in cGMP pharmaceutical industry
• Strong attention to detail and knowledge of pharmaceutical processes and protocol around analytical instruments and computer systems
• Experience in implementing and maintaining GXP computer systems in a validated state
• Experience in defining requirements, translating them between the development and business facing teams and documenting them for GxP
• Ability to comprehend computer systems applications and GMP
• Strong understanding of a cGMP environment
• Experience with Quality Management Systems and good documentation practices
• Basic analytical instrumentation troubleshooting skills
• Excellent problem-solving skills and root cause analysis
• Understanding of regulatory guidelines such as Z540, ISO 9001, ISO 17025, cGMP, and GAMP5
• Able to be aware of all relevant SOPs as per Company policy as they are related to the position covered by this Job Description
• Support and contribute to Lean Sigma programs and activities towards delivery of the set target
• Able to comply with the company’s safety and quality policies at all times

Travel Requirements

Physical Requirements

Additional Requirements

• Must be able to work assigned shift(s) with overtime as required to complete assignments if necessary.
• Sitting and/or standing for extended periods may occur as well as getting to and from offices and building sites.
• If specifically necessitated by customer requirements, must be able to see with or without corrective lenses and distinguish color differences for product and safety issues. Hearing ability should be sufficient to hear and react to audible alarms from distances up to 150 feet.
• The ability to lift and carry various items up to 50 pounds for manufacturing positions or 30 pounds for administrative positions as required.
• Handling of biohazard material and components.