Principal Engineer - Bioprocess Clinical Manufacturing Technology - FSP

Responsibilities

• Media & Bulk Product Support Material Release Management: 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.
• Workflow Coordination: 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.
• Data Integrity: Ensure all sample tracking data is entered and maintained with strict adherence to ALCOA+ principles.
• Documentation & SOPs Document Lifecycle Management: Draft, author, initiate, review, and approve critical GMP documentation (such as batch records, forms, and technical reports).
• Continuous Improvement: Actively review existing documentation for clarity, compliance, and process optimization, ensuring all materials align with current regulatory standards and internal quality policies.
• Workflow Tracking: Drive document workflows through electronic document management systems from draft to final approval.
• Quality & Compliance Audit Readiness & Execution: Facilitate and actively participate in internal audits and external agency inspections (e.g., FDA, EMA).
• Logistical Support: Assist in the preparation of audit materials, support front-room/back-room logistics, and provide real-time documentation retrieval during active inspections.
• Compliance Culture: Champion a culture of quality by ensuring daily operations remain in a constant state of inspection readiness.
• Training & Development Knowledge Transfer: Deliver targeted, comprehensive training to relevant personnel on new procedures, system updates (like RLIMS2), and GMP compliance standards.
• Training Effectiveness: Evaluate the effectiveness of training sessions and ensure all staff understand the practical application of SOPs in their daily tasks.
• Record Maintenance: Ensure accurate tracking of training completion within the learning management system.

Qualifications

• 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.

About the role

Parexel FSP includes the CMC Operations group. We provide pharmaceutical and biopharmaceutical companies with qualified and talented technical professionals to support the development and delivery of new therapies. For results-driven and caring individuals who want to make a meaningful difference in the world, 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, and where an inclusive community helps you be your best, transforming any career into a life-changing achievement. Come join us!