Senior Engineer – Commissioning and Qualification

Senior Engineer – Commissioning and Qualification

Requirements

• Bachelor’s degree or equivalent in scientific discipline
• Quality professional with a minimum of 5 years’ relevant experience in the life science industry including 5 years in equipment qualification and/or computer system validation (cleaning validation knowledge is a plus)
• Requires knowledge of FDA regulated biotechnology or drug validation requirements (e.g. 21 CFR 210, 211 or ICH Q7)
• Knowledge of GEP and GAMP-5, integrated C&Q process, application of risk management to GEP and GAMP-5 and relationship between CQAs, CPPs, CAs, CDEs and the associated testing.
• Experience executing validation projects for biotech or pharmaceutical projects
• Must have specific knowledge of validation methodologies and principles
• Strong technical writing and analytical skills
• Expertise in risk management and application of FMEAs to validations.

Responsibilities

• Provide Commissioning and Qualifications guidance and participate in URS development, System Impact Assessment and System Risk Assessment, establishing system boundaries and traceability matrix to support C&Q deliverables
• Audit Preparation and Readiness with Quality, Compliance and Safety
• Change controls, deviations/exceptions, investigations, corrective/preventive actions, root cause analysis
• Responsible for reviewing technical requirement specifications and Commissioning and Qualifications lifecycle documentation such as URS, FRS, SIA, SRA, Commissioning and Qualification tests, P&IDs, FAT, SAT
• Accountable for Commissioning and Qualifications activities supporting the site FUE
• Support Asset Management and Decommissioning
• Leads, develops, executes and documents FUE IOPQs, Cleaning Validation, and Computer System Validation using Good Documentation and Good Engineering Practices, GDP and GEP
• Revise and maintain equipment lifecycle documentation, policies, standards and procedures related to Commissioning and Qualifications, GEP and GAMP-5
• Coordinates qualification activities/deliverables with internal and external partners to ensure projects are carried out on time
• Mentor and coach engineering, manufacturing, and quality personnel on the best practices for qualification and validation
• Maintains up-to-date knowledge of validation requirements, practices and procedures across industry
• Manage oversight of 3rd party organizations with inspections, document redline, review of Commissioning and Qualifications supporting documentation
• Assure compliance with all-in-house or external specifications to standards, such as ISO, GMP and 21 CFR Part 11
• Ensures adherence and compliance to pre-start up safety checks, LOTO and site safety programs specifications to standards, such as ISO, GMP and 21 CFR Part 11
• Perform other functions and duties as required

Preferred Qualifications

• Experience in validating CMMS is a plus
• Experience in the use of MS Project, Master Control, eMaint, Rees is a plus