Responsibilities - Performs work in compliance with PM Group's Service Delivery Platforms and Quality Management System (QMS)
- Independently interact with client to assess and continuously reassess client needs
- Perform quality GAP analysis
- Author technical and scientific reports
- Demonstrates an understanding of project scope of work assigned
- Demonstrates an understanding of commercial aspects (hours and capital cost) of their work
- Delivers scope of work within budgeted hours
- Document development as well as testing execution to meet client qualification needs
- Applying the principals of good documentation practices (CGDP)
- Collaborate in a multi discipline team environment
- Perform qualification protocols and review other team members qualification documents
- Ensure the implementation of current good manufacturing practices (CGMP)
- Independently assess the qualification needs of equipment, facilities, utilities and systems
- Provide technical guidance to less experience CQV team members
- Special projects as assigned
Qualifications - Bachelor's degree is required; an engineering degree is preferred
- 5-10 Years of CQV experience in the Pharmaceutical, Life Sciences, Biotech and/or Cell & Gene Therapy industries
- Factory site acceptance testing (FAT) and site acceptance testing (SAT) experience
- Proven experience with commissioning pre-functional checklist (PFC) development and commissioning functional performance testing (FPT)
- Experience working with current good engineering and current good manufacturing practices
- Understand client needs and provide assistance with the development of user requirements specifications (URS) and system impact analysis (SIA)
- Demonstrated experience working in an industry regulated life sciences environment
- Actively participant in the document approval process
- Understanding of the entire validation life cycle and change control process
- Experience reviewing vendor supplied documents such as submittal sheets and turn over packages (TOPs)
- Familiar with and understand the basics of design drawings
- Full understanding of all commissioning, qualification and validation (CQV) testing procedures
- Ability to document and execute cleaning validation procedures
- Knowledge of cGMP Manufacturing environments is required
- Good technical reporting writing skills are mandatory
- The ability to travel as needed for client development and project execution
Pay Range Disclosure: The pay range for this position is $100,000 - $130,000 annually. This range represents the base salary that PM Group reasonably expects to pay for this role at the time of posting. The actual compensation offered will depend on factors such as work location, qualifications, skills, and relevant experience.
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