Blackfield Associates are currently partnered with a large pharmaceutical manufacturer to support their search for a Senior Process Engineer to join their project based near Brussels on an initial 12-month contract.
Key Responsibilities
Lead process engineering activities from design through commissioning and handover of upstream and downstream bioprocess equipment.
Act as the single point of contact for all process equipment, coordinating with suppliers, users, QA, EHS, and commissioning teams.
Oversee equipment transfer, integration, and automation upgrades (PCS7), ensuring alignment with pilot plant systems.
Manage and execute FAT/SAT, verification, and commissioning documentation in accordance with ASTM E2500.
Lead development and review of P&IDs, PFDs, and technical documentation.
Support qualification and validation activities, including HAZOP, QRA, and FMEA.
Ensure compliance with GMP, GLP, and global engineering standards.
Provide technical training and documentation to end users and support efficient handover.
Monitor construction progress, perform field quality checks, and coordinate milestone activities.
Maintain up-to-date knowledge of bioprocess technologies and automation systems.
Experience Required
Sufficient experience in pharmaceutical engineering, with a focus on large-scale CAPEX projects.
Strong technical expertise in upstream and downstream single-use bioprocess equipment (e.g., bioreactors, UF/DF skids, chromatography systems).
Deep understanding of GMP, GEP, and regulatory guidelines (FDA, ICH, ISPE).
Experience leading cross-functional teams and managing complex engineering deliverables.
Fluent in English; French language skills are highly desirable.
Bachelor’s or Master’s degree in engineering or a related field.