CQV Project Lead – Pharma & Biotech Validation

IPS-Integrated Project Services; Center Square (PA); On-site; USD 120,000 - 160,000; Full time

Job summary

IPS-Integrated Project Services seeks an experienced Project Manager of CQV to lead commissioning, qualification, and validation for pharmaceutical, biotech, and medical device facilities at client sites in Blue Bell, PA. You will direct multi-project delivery, manage budgets, and maintain client relationships.

You will mentor commissioning engineers, contribute to proposals, and ensure adherence to cGMP standards and IPS practices.

Qualifications

• Bachelor’s degree in Engineering, Project Delivery, or related discipline or 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 issues, and coordinates activities.
• Perform work to meet IPS budget requirements and quality standards; provide feedback and reports on status and issues.
• Develop project schedules, deliverable tracking reports, and scope adjustment notices.
• Support, train, mentor, and guide commissioning and validation staff on project delivery.
• Assist in proposal development, including scope, hours and cost budgets, and client presentations.
• Write and manage C/Q/V documents per standards: Master Plans, Protocols, SOPs, Impact Assessments, URS/FRS/DDS, etc.
• Attend FATs/SATs, witness vendor start-up, execute C/Q/V protocols, and verify drawings (P&IDs, as-builts).
• Compile data packages and reports for completed C/Q/V activities; manage deviations and audit project deliverables.
• Develop client relationships and IPS liaison on sites; contribute to new opportunities.

Skills

Project management

CQV

cGMP

Leadership

Client relations

Budgeting

Mentoring

Education

Bachelor’s degree in Engineering

Tools

PMP

PE license

Job description

IPS-Integrated Project Services seeks an experienced Project Manager of CQV to lead commissioning, qualification, and validation for pharmaceutical, biotech, and medical device facilities at client sites in Blue Bell, PA. You will direct multi-project delivery, manage budgets, and maintain client relationships.

You will mentor commissioning engineers, contribute to proposals, and ensure adherence to cGMP standards and IPS practices.