Validation Lead

i-Pharm GxP; Massachusetts; On-site; USD 150,000 - 210,000; Full time

Job summary

i-Pharm GxP is partnering with a growing sterile CDMO in Massachusetts to bring on an experienced CQV Lead to support multiple capital equipment and process projects across two manufacturing lines.

This is a key role on site. You will own the CQV strategy for the projects, challenge timelines and set the team up for successful startup and regulatory readiness.

Qualifications

• 8+ years of CQV experience in pharma/biotech/CDMO settings with a lead/ownership role.
• Authoring VPPs and qualification strategies beyond protocol execution.
• Experience qualifying equipment and processes in sterile/aseptic manufacturing.
• Strong knowledge of cGMP, FDA expectations and risk-based approaches (e.g., ASTM E2500).
• Able to work independently and drive vendors and stakeholders to timelines.

Responsibilities

• Own the commissioning, qualification and validation strategy for new equipment and processes across two lines.
• Author and approve Validation Project Plans and qualification strategies.
• Review CQV schedules, challenge durations and build realistic execution plans.
• Oversee IQ/OQ/PQ protocol development and vendor CQV work.
• Develop startup documentation to support regulatory submissions.
• Coordinate with Engineering, Quality, Manufacturing and OEMs to keep projects on track.
• Report CQV progress and risks to project steering committees.

Job description

i-Pharm GxP is partnering with a growing sterile CDMO in Massachusetts to bring on an experienced CQV Lead to support multiple capital equipment and process projects across two manufacturing lines.

This is a key role on site. You will own the CQV strategy for the projects, challenge timelines and set the team up for successful startup and regulatory readiness.

Key responsibilities

• Own the commissioning, qualification and validation strategy for new equipment and process installations across two manufacturing lines
• Author and approve Validation Project Plans (VPPs), qualification strategies and risk assessments
• Review and challenge CQV schedules and durations, and build realistic execution plans
• Oversee IQ/OQ/PQ protocol development and execution, including work by third-party CQV vendors
• Develop startup and qualification documentation to support regulatory submissions
• Work closely with Engineering, Quality, Manufacturing and OEMs to keep projects on track
• Report CQV progress and risks into project steering committees

What we're looking for

• 8+ years of CQV experience in pharma, biotech or CDMO environments, with time in a lead or ownership role
• Proven track record authoring VPPs and qualification strategies, not just executing protocols
• Experience qualifying equipment and processes in sterile or aseptic manufacturing
• Strong working knowledge of cGMP, FDA expectations and risk-based approaches such as ASTM E2500
• Confident working independently and holding vendors and stakeholders to timelines