Process Engineer
vor 2 Wochen
The Process Engineer plays a pivotal role in ensuring seamless internal and external manufacturing operations, driving continuous improvement and innovation. This position offers a unique opportunity to work with a well-established pharmaceutical company, leveraging diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities, and Validation.
- Collaborate with external partners to achieve business objectives and foster a unified culture.
- Act as the primary interface for technical issues between operations and external partner manufacturers, leading and coordinating transfer activities.
- Develop and review technical documentation, including Master Batch Records, change control, protocols, reports, qualifications, and regulatory filings.
- Manage commercial manufacturing processes at external partners, overseeing process improvement projects, statistical analysis, and atypical event investigations.
- Apply innovative solutions to complex technical challenges, driving ingenuity and creativity.
- Provide on-site support at external partners, ensuring commercial and technical transfer activities run smoothly.
- Translate GMP requirements and current regulations into actionable strategies, partnering with operations, quality, and external partners.
- Ensure external partners are inspection-ready for routine and new product-related inspections.
- Contribute to creating, sharing, and adopting best practices and business strategies.
To succeed in this role, candidates should possess:
- A Bachelor's degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or a related field.
- A minimum of 3-5 years of experience in GMP functional areas or support roles, such as Operations, Technical Operations, Technology, or Engineering.
- Excellent English language skills, both written and spoken.
- Ability to work independently and demonstrate strong organizational skills.
- Superb professional and interpersonal communication skills.
- Capacity to multitask and meet tight deadlines.
- Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation.
- Proven team building skills.
This position offers high flexibility, with the possibility of 100% remote work. A willingness to travel (approximately 25%) is required.
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