Process & Validation Project Manager (a minimum of 5 years of experience required)
Location: Philadelphia, PA
Employment Type: Full-time, mostly onsite
The Process & Validation Project Manager is responsible for leading the coordination of projects of various systems across the pharmaceutical, biopharmaceutical, and medical device manufacturing sectors.
The Process & Validation Project Manager will live near Philadelphia, PA. They will be motivated to grow and excel with the support and direction from an interdisciplinary team of engineers. Become part of a supportive work environment that emphasizes team culture and empowering engineers with more responsibility, professional growth, and a work-life balance.
Responsibilities and Duties:- Plan, coordinate, and execute facility improvement projects, including scope definition, scheduling, contractor coordination, and closeout documentation.
- Serve as the primary on-site liaison for all project-related activities, ensuring minimal disruption to GMP operations and maintaining a safe working environment throughout project execution.
- Initiate, author, and shepherd change control records through the site quality management system (QMS) in accordance with GMP change control procedures.
- Coordinate and support the vendor approval and qualification process for new contractors and service providers, partnering with Procurement and QA as required.
- Develop and maintain project schedules, status trackers, and progress reports for review by site leadership.
- Identify and escalate project risks, scope changes, and schedule impacts in a timely manner, proposing mitigation strategies as appropriate.
- Ensure all project activities comply with applicable GMP regulations, site SOPs, EHS requirements, and local building codes.
Qualifications: - Bachelors degree in engineering field or relevant equivalent.
- Minimum 5 years of prior experience preparing and executing equipment qualification documents (IQ/OQ/PQ) required.
- Excellent knowledge of the Current Good Manufacturing Practices.
- Excellent communication skills - verbal, written, listening and interpersonal with the ability to transfer knowledge to others.
- Strong technical knowledge, relationship management, organizational planning, and project management skills.
- Ability to demonstrate a sense of urgency, flexibility, and accountability.
- Flexibility to travel to the client site as required.
Preferred Qualifications - Prior experience performing GxP risk assessments such as Functional Risk Assessments (FRA) or Failure Mode and Effect Analysis (FMEA).
- Experience in Aseptic Processing.
- Familiarity with Computerized Systems Validation and ISPE GAMP5 and 21 CFR Part 11.
Send us your application today. We look forward to meeting you!
The LAPORTE team
