Principal Engineer - Bioprocess Clinical Manufacturing Technology - FSP
About The Position
Parexel FSP is seeking a Principal Engineer to work as a full-time employee on a long-term assignment onsite at one of their clients located in West Point, PA. The ideal candidate will have a strong background in pharmaceutical/biotech manufacturing and quality systems, with proven expertise in documentation, compliance, and training within a GMP environment. This role is highly focused on supporting raw material release workflows, maintaining strict GMP documentation standards, and ensuring compliance during audits. Parexel FSP provides pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. Parexel is trusted by life sciences companies to meet their long-term staffing needs for scientists and engineers and related professionals in discovery and development of novel therapies, keeping patients at the center of everything we do.
Requirements
- B.S. / B.A. in the biological sciences, engineering, or equivalent technical discipline.
- Proven experience working in a GMP-regulated pharmaceutical, biopharmaceutical, clinical trial supply, or biotech manufacturing environment.
- Hands-on experience with Laboratory Information Management Systems, specifically RLIMS2, and managing SWMS requests.
- Strong technical writing skills with demonstrated experience in authoring, editing, and reviewing GMP-compliant documentation.
- Familiarity with audit preparation, coordination, and front-room/back-room logistics.
Responsibilities
- Actively support the timely release of raw materials and culture media by precisely managing RLIMS2 item codes, executing sample log-ins, and generating sample numbers to keep manufacturing timelines on track.
- Process sample submission forms and accurately manage SWMS requests, serving as a liaison between manufacturing, quality control, and supply chain teams to prevent operational bottlenecks.
- Ensure all sample tracking data is entered and maintained with strict adherence to ALCOA+ principles.
- Draft, author, initiate, review, and approve critical GMP documentation (such as batch records, forms, and technical reports).
- Actively review existing documentation for clarity, compliance, and process optimization, ensuring all materials align with current regulatory standards and internal quality policies.
- Drive document workflows through electronic document management systems from draft to final approval.
- Facilitate and actively participate in internal audits and external agency inspections (e.g., FDA, EMA).
- Assist in the preparation of audit materials, support front-room/back-room logistics, and provide real-time documentation retrieval during active inspections.
- Champion a culture of quality by ensuring daily operations remain in a constant state of inspection readiness.
- Deliver targeted, comprehensive training to relevant personnel on new procedures, system updates (like RLIMS2), and GMP compliance standards.
- Evaluate the effectiveness of training sessions and ensure all staff understand the practical application of SOPs in their daily tasks.
- Ensure accurate tracking of training completion within the learning management system.
Benefits
- full benefits
- sick time
- 401K
- paid holidays
- paid time off
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
