Process & Validation Project Manager

Process & Validation Project Manager (a minimum of 5 years of experience required)

Location: Philadelphia, PA

Employment Type: Full-time, mostly onsite

About Us

Are you ready to take the next step in your career? LAPORTE, a consulting engineering firm with 25 years of experience and a strong presence in North America and Europe, is seeking an Process & Validation Project Manager to join our growing team. With 25 offices and over 480 employees worldwide, we specialize in delivering innovative solutions for the pharmaceutical and food & beverage industries.

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.

At LAPORTE, we offer:

• Competitive Salary
• Comprehensive Benefits
• Compensatory Paid Time Off (PTO)
• Paid Parental Leave
• A Flexible Work Environment that values work-life balance
• Opportunities for Professional Growth

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.