Process & Validation Project Manager

LAPORTE L.C.C.•Philadelphia, PA

17h•Onsite

About The Position

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 their growing team. With 25 offices and over 480 employees worldwide, they 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.

Requirements

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.

Nice To Haves

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.

Responsibilities

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.