Process Engineer III
Vor 7 Tagen
Large Molecule DS Tech Ops, Lucerne
Fulltime. Duration: 1 year duration with option of an extension. Home office: 100% remote with 20% travel requirements.
This is an exciting opportunity to work with key strategic external partners, grow technical experience in biologics or vaccines manufacturing, and work on high visibility network initiatives. Our Engineers help ensure that internal and external manufacturing operations remain operational, continuously improve, and innovate.
Responsibilities:- Work with external partners to achieve business goals and to establish a common culture that benefits both our company, external partners, and patients.
- Lead and act as the primary interface on technical issues between technical operations and external partner drug substance manufacturers.
- Conduct technical transfer activities, as applicable, through authorship and/or review of required GMP documentation (Master Batch Records, change control, qualifications, etc.), regulatory filings.
- Perform 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.
- Develop solutions to complex technical issues that require a high degree of ingenuity, creativity, and innovation. This requires understanding and application of principles, concepts, practices, and standards that govern the manufacturing of sterile products.
- Provide on-site coverage at external partners in support of commercial and/or tech 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 and quality.
- 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.
- Participate in creating, sharing, and adopting best practices and business process strategies.
- Bachelor’s degree in Chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field.
- Minimum of 7 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area, such as Operations, Technical Operations, Technology, or Engineering.
- Strong professional and interpersonal communication skills.
- Strong analytical problem-solving skills, root cause analysis, and risk assessment/mitigation.
- Proven team building skills.
- Excellent command of English (both written and oral), German is an asset.
- Travel will be a requirement of this position at approximately 20%.
- Experience in biologics drug substance manufacturing is preferred.
- Project management experience is preferred.
- Experience in deviation management and/or change control and/or equipment support is preferred.
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