Jobs in Luton, Francia

Senior Process Engineer is required by CareerWise Recruitment for a Biotechnology client. This is a 12-month contract. Must Have Drug Substance Technical Transfer Experience for this role. This is a 100% remote based position.

• Work with External Partners to achieve business goals and establish a common culture that benefits our company, External Partners, and patients.
• Responsible for technical activities for the commercial manufacturing process at the External Partner, including authorship of change control, management of process improvement projects, statistical analysis of process performance, and investigation of atypical events.
• Responsible for technical transfer activities, such as authorship and review of GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) and regulatory filings.
• Provide on-site support at External Partner facilities for Commercial and Technology Transfer activities.
• Translate GMP requirements and current regulations into standardized work procedures in collaboration with Operations, Quality, and External Partners.
• Ensure External Partners are inspection-ready for routine and special inspections related to new product introductions or transfers, in coordination with Operations, Quality, and Regulatory teams.
• Participate in developing, sharing, and implementing best practices and business process strategies.

• Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, Chemistry/Biology, or related field.
• Minimum of 4 years of post-bachelor's degree experience in a GMP-related area or supporting GMP activities, such as Operations, Technical Operations, Technology, Engineering, or Maintenance.
• Must have Drug Substance Technical Transfer experience (4-5 years).