CQV Project Lead - GMP Validation & Commissioning

IPS - Integrated Project Services, LLC; Burlington (MA); On-site; USD 113,200 - 150,900; Full time

Job summary

IPS - Integrated Project Services, LLC is seeking a Project Manager of CQV to lead commissioning, qualification and validation projects in the New England region. The role interfaces directly with clients, drives meetings, tracks deliverables, and maintains project schedules and budgets.

You will mentor commissioning and validation teams, contribute to proposals, and ensure adherence to cGMP standards for pharmaceutical, biotech, and medical device programs.

Qualifications

• Bachelor's degree in Engineering, Project Delivery, or a related discipline, or an equivalent technical degree.
• 7+ years of experience in Pharmaceutical, Biotech, Medical Device Design, Construction, Commissioning, Validation, or QA.
• Experience with Risk-Based Approach to Commissioning and Qualification.

Responsibilities

• Directly responsible for the successful delivery of commissioning and compliance projects to IPS' clients.
• Leads multiple concurrent small, mid-sized, or large projects on behalf of IPS.
• IPS point of contact to the client for overall project delivery. Runs meetings, communicates status and project issues, frequently checks in with client representative(s), and facilitates general project coordination activities.
• Coordinates project activities with the IPS Project Lead.
• Perform work to meet IPS budget requirements and quality standards. Provide consistent, complete, and timely feedback and reports to IPS clients or management on project status and issues.
• Develop project schedules, deliverable tracking reports, scope adjustment notices, etc.
• Support, train, mentor, and guide commissioning and validation specialists/engineers and project leaders in the delivery of C/Q/V services for assigned projects.
• Assist or take lead in proposal development, including scope definition, attending bid meetings, development of hours and cost budgets, proposal presentations, etc.

Education

Bachelor's degree in Engineering, Project Delivery, or related discipline

Equivalent technical degree

Job description

IPS - Integrated Project Services, LLC is seeking a Project Manager of CQV to lead commissioning, qualification and validation projects in the New England region. The role interfaces directly with clients, drives meetings, tracks deliverables, and maintains project schedules and budgets.

You will mentor commissioning and validation teams, contribute to proposals, and ensure adherence to cGMP standards for pharmaceutical, biotech, and medical device programs.