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Your next role as a Miracle Maker 

Maravai LifeSciences is seeking a #MiracleMaker to join our engineering team as a Senior C&Q Engineer. As a Senior C&Q Engineer you will provide critical guidance in the development of User Requirement Specifications (URS), System Impact Assessments, and risk assessments while ensuring compliance with industry standards such as ISO, GMP, and 21 CFR Part 11. The Senior C&Q Engineer will oversee qualification activities, mentor cross-functional teams, and manage documentation related to equipment lifecycle and validation processes. This role is essential for maintaining the quality and integrity of our operations, contributing to successful project execution and adherence to safety protocols.

How you will make an impact:

• Provide C&Q 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 C&Q lifecycle documentation such as URS, FRS, SIA, SRA, Commissioning and Qualification tests, P&IDs, FAT, SAT
• Accountable for C&Q 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 C&Q, 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 3^rd party organizations with inspections, document redline, review of C&Q 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 

 The skills and experience that you will bring: 

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

 #LI-Onsite