Senior Technical Transfer Engineer - Oss

• Responsible for technical activities for the commercial manufacturing process at the External Partner, which includes authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
• Responsible for technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
• Provide on-site coverage at External Partner in support of Commercial and / or Technology Transfer Person-In-Plant Activities.
• Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners.
• Ensure that External Partners are inspection ready for all routine inspections and / or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory.
• Responsible for participation in creating, sharing, and adopting best practices and business process strategies.

The ExM Tech Ops team is looking for a motivated professional for a Technical Transfer role. The team manages technology transfers and commercial production of biologics at External Partners. The role includes supporting transfer execution, resolving production issues, and contributing to process and capacity optimization.

This is your opportunity to explore a wide range of industries and activities while developing your expertise in a fast-paced, results-driven environment.

Being placed by Brunel means you will have a contract with us. Not only do you get a contract, but you're also assured of a promising career! Our primary and secondary employment conditions are excellent.

We also offer you:

• A gross monthly salary up to €6,500 depending on experience.
• Extensive training and development opportunities through the Brunel Academy
• Travel expense reimbursement
• 8% holiday allowance
• A pension scheme and collective health insurance
• Discounts on gyms, cultural activities, and vitality programs

• Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
• Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, Engineering, and/or Maintenance
• Travel will be a requirement of this position at approximately 25%
• Strong communication in English and teamwork skills
• Proven expertise in biologics drug substance upstream and downstream operations, analytical testing, process development and tech transfer.
• Demonstrated ability to independently manage projects/work to schedule/deadlines
• Statistics experience (including Proactive Process Analysis and Continuous Process Verification)
• Experience in deviation management and/or change control and/or equipment support, and/or project management.
• Dutch not required.