Technical Transfer Process Engineer (m/f/d)
Responsibilities
- Work with External Partners to achieve business goals and to 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, 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
Profile
- Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field
- 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
- 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) advantageous
- Experience in deviation management and/or change control and/or equipment support, and/or project management advantageous
Benefits
- Multinational environment
- Career growth
About Hays
Our many years of recruitment experience and our expert knowledge of the engineering job market make us a strong partner for engineers and technicians. We maintain close relationships with customers across all industries and therefore can provide engineering specialists with exciting projects and attractive job opportunities, drawing on your personal interests and experience. As your professional companion, we support you throughout the entire process, from the first contact to the first day on your new job – all this completely free of charge. Register now and look forward to many interesting and suitable positions and projects.
Staffing process for freelance specialists
- Analysis of qualifications
- Telephone or personal interview
- Contact with customers
- Contract with Hays
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1. Analysis of qualifications
We carry out a detailed analysis of your technical qualifications on the basis of your CV, your application documents and your profile.
Contact at Hays
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