SRG, the leader in the Life Sciences human capital industry, is looking for an experienced CQV (Commissioning, Qualification, and Validation) Lead/PM to support a major site expansion project in South Carolina.

*Fully onsite position

*Rate will be discussed based on years of experience

Must Haves:

• Bachelor's degree in Engineering, Life Sciences, or related field.
• 8+ years of experience in CQV roles within pharmaceutical or CDMO environments.
• Proven experience leading validation efforts for site expansions or greenfield projects.
• Strong knowledge of modular construction and its impact on CQV planning and execution.
• Expertise in utility system qualification and GMP compliance.
• Modular Construction
• Utility System Qualification and Site Expansion experience
• CQV Lead / PM perspective

Preferred:

• Previous experience supporting CDMO operations.
• Familiarity with mid-sized pharma manufacturing environments.
• PMP certification or formal project management training is a plus.

Responsibilities:

• Lead all CQV activities related to the site expansion, ensuring alignment with project timelines and regulatory requirements.
• Develop and manage the Validation Master Plan (VMP) and associated documentation.
• Develop an validation project management plan including lifecycle management of the VMP through the end of execution, oversight of CQV protocol generation and oversight of CQV execution that aligns with project schedule.
• Review URS / PID? PFD documents for the project, develop protocol for FAT and SAT commissions and generate IQ / OQ / PQ protocols.
• Oversee commissioning and qualification of utility systems, including:
• HVAC
• Purified Water (PW) Systems
• Clean Steam
• Compressed Air
• Other critical utilities

** Only candidates selected to be moved forward in the recruitment process will be contacted by SRG's Recruitment Team to schedule a conversation.

Impellam Group and its brands are equal-opportunity employers committed to diversity and inclusion. All qualified applicants will receive consideration without regard to race, color, religion, gender, sexual orientation, pregnancy or maternity, national origin, age, disability, veteran status, or any other factor determined to be unlawful under applicable law. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application, interview process, pre-employment activity, and the performance of crucial job functions.

If you require additional disability considerations, modifications, or adjustments please let us know by contacting HR-InfoImpellamNA@impellam.com or fill out this form to request accommodations.