Process Engineer
vor 1 Woche
The Process Engineer will play a crucial role in ensuring the smooth operation of internal and external manufacturing processes, driving continuous improvement and innovation.
Key Responsibilities:- Collaborate with external partners to achieve business objectives and foster a shared culture
- Lead technical issues between operations and external partner drug substance manufacturers, serving as the primary interface
- Author and review GMP documentation, including Master Batch Records, change control, protocols, reports, qualifications, and regulatory filings
- Oversee technical activities for commercial manufacturing processes at external partners, including change control, process improvement projects, statistical analysis, and atypical event investigation
- Develop creative solutions to complex technical challenges
- Provide on-site support at external partners for commercial and tech transfer activities
- Translate GMP requirements and develop standardized work to meet regulatory needs, partnering with operations, quality, and external partners
- Ensure external partners are inspection-ready for routine and new product introductions or transfers, in collaboration with operations, quality, and regulatory
- Contribute to creating, sharing, and adopting best practices and business process strategies
To be considered for this position, the ideal candidate should possess:
- A bachelor's degree in chemical/biochemical engineering, pharmaceutical science, or a related field
- At least 3 years of experience in technical operations, pharmaceuticals, upstream, and downstream
- Excellent English language skills (written and oral), with German being an advantage
- Ability to work independently and possess excellent organizational skills
- Strong professional and interpersonal communication skills
- Ability to multitask and work under tight deadlines
- Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation
- Proven team building skills
This role offers high flexibility, with the possibility of working 100% remotely, while requiring a willingness to travel (approximately 20%).
This is an excellent opportunity to join a well-known and prestigious pharmaceutical company with an extension option.
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