Website Asset Recruitment
Asset Recruitment
ref. 01112
Process Engineer (Technical Transfer)
Our client, a leading multi-national Biotech company, is seeking enthusiastic candidates to join their External Manufacturing (ExM) Technical Operation team. As part of Ex Tech Ops, you will support technology transfers and oversee Large Molecule Drug Substance production at our External Partners (EPs). You will engage in various aspects, from facilitating technology transfers to troubleshooting production issues and enhancing process efficiency.
Responsibilities:
– Lead technical activities for commercial manufacturing processes at External Partners, including change control, process improvement initiatives, performance analysis, and investigating irregular events.
– Collaborate with External Partners to align on mutual business objectives, fostering a unified culture benefiting our company, partners, and patients.
– Interpret regulatory standards and operational needs, developing standardized practices in coordination with Operations, Quality, and External Partners.
– Manage technical transfer activities, ensuring compliance with documentation requirements (e.g., Master Batch Records, change controls, protocols, reports) and regulatory filings.
– Offer on-site support at External Partner facilities for Commercial and Technology Transfer Person-In-Plant Activities.
– Prepare External Partners for inspections, aligning efforts with Operations, Quality, and Regulatory teams.
Requirements:
– Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or related field.
– Minimum 4 years of GMP-related experience post-bachelor’s degree, specifically in Operations, Technical Operations, Technology, Engineering, or Maintenance.
– Extensive experience in Drug Substance Technical Transfer (4/5 Years).
– Willingness to travel approximately 25%.
– On-site presence.
– Strong communication and teamwork skills.
Preferred Skills:
– Proficiency in biologics drug substance upstream/downstream operations, process development, and tech transfer.
– Experience in deviation management, change control, equipment support, and/or project management.
– Demonstrated project management ability, meeting deadlines independently.
– Statistical expertise, including Proactive Process Analysis and Continuous Process Verification.