KPC International - Excellence from Concept to Completion
KPC International began operations in 2001, our team of Engineers and Scientists have helped our clients achieve project success all over the world within the pharmaceutical and biopharmaceutical space.
We specialise in Plant Facility Start-Up from Strategy and Planning to Execution, through to Operational Readiness. We are proud to support our clients in delivering their life changing products to patients.
We are currently seeking 3 x MSAT Process Engineers for 12 month contracts starting in January 2025. Experience in an MSAT function is essential.
The Manufacturing Science, Analytical and Technology department (MSAT) represents the scientific backbone of the company that provides commercial manufacturing support, process/method optimization (lifecycle management), technology transfer of new products and processes/methods and development of innovative, robust, and cost-effective next-generation processes/methods.
This role focuses on the upstream cell culture part of the biopharmaceutical manufacturing process. Leveraging strong scientific and technical knowledge, you will actively contribute to Technology Transfer activities facilitating the introduction of new products and processes at the clients manufacturing site in Geel. Additionally, you will support improvement initiatives and the ongoing monitoring of existing processes, both at the Geel site and within the broader network. The position primarily focuses on manufacturing-scale activities, but involves a strong collaboration with the laboratory team on laboratory-scale activities.
Tasks
* Support the introduction of new drug substance manufacturing processes by facilitating the technology transfer from development laboratories to large-scale GMP manufacturing facilities. This includes ensuring documentation readiness (e.g., conducting process fit-gap analyses, defining process control strategies, preparing media batch sheets and sampling plans) for clinical batch production, as well as providing support during process performance qualification to successfully implement new processes at manufacturing scale.
* Identify and lead process improvement initiatives to increase process yield or robustness, and generate supportive data packages to enable implementation at manufacturing scale.
* Provide ongoing support for existing commercial manufacturing processes through activities such as data trending and monitoring, developing scientific and technical study protocols and reports to support significant process changes, and contributing to investigations and process/product impact assessments for significant manufacturing deviations.
Skills
* PhD or Master’s degree in Life Sciences with a minimum of 3 years (PhD) or 5 years (Master’s) relevant experience in process development or MSAT-like roles.
* Fluent in oral and written English to effectively operate in an international environment.
* Hands-on experience with mammalian cell culture processes at laboratory and/or manufacturing scale; familiarity with purification processes is considered an advantage.
* Flexibility: Willingness to adapt to dynamic work demands, including occasional evening or weekend shifts, and supporting both small-scale lab studies and manufacturing-scale operations.
* A team player who works effectively across multidisciplinary teams and fosters productive relationships.
* Ability to adjust to shifting priorities in a fast-paced environment.
* Strong interpersonal skills to connect with colleagues, facilitate discussions, and negotiate compromises with other departments or sites.
* A precise, detail-oriented mindset with excellent analytical skills for identifying and addressing challenges.
* Familiarity with statistical and data trending techniques; experience with tools like JMP, Statistica, Matlab, or Simca is a plus. A solid understanding of current Good Manufacturing Practices (GMP); prior GMP experience is an asset.
KPC -International offers an inclusive environment where you can broaden your experience, perspective and skills to help make an impact on the lives of others.
KPC – International is an Equal Opportunity Employer.
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