Process Engineer
vor 3 Wochen
The Process Engineer will play a crucial role in ensuring the smooth operation of internal and external manufacturing processes. This includes identifying areas for improvement and implementing innovative solutions to enhance efficiency and productivity.
Key Responsibilities:- Collaborate with external partners to achieve business objectives and foster a culture of collaboration.
- Lead technical discussions and serve as the primary interface between technical operations and external partner drug substance manufacturers.
- Develop and review GMP documentation, including Master Batch Records, change control, protocols, reports, qualifications, and regulatory filings.
- Manage commercial manufacturing processes at external partners, including authorship of change control, process improvement projects, statistical analysis of process performance, and investigation of atypical events.
- Develop creative solutions to complex technical issues.
- Provide on-site support at external partners for commercial and/or tech transfer activities.
- Translate GMP requirements and current regulations into standardized work processes, partnering with operations, quality, and external partners.
- Ensure external partners are inspection-ready for routine and new product introductions or transfers, in concert with operations, quality, and regulatory.
- Contribute to the creation, sharing, and adoption of best practices and business process strategies.
- Bachelor's degree in chemical/biochemical engineering, pharmaceutical science, or chemistry/biology, or related field.
- At least 3 years of experience in technical operations, pharmaceutical, upstream, and downstream.
- Excellent command of English (written and oral), German an advantage.
- Ability to work independently and possess excellent organizational skills.
- Strong professional and interpersonal communication skills.
- Ability to multi-task 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, with a willingness to travel required (approximately 20%).
Join a well-known and prestigious pharmaceutical company with an extension option.
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