Company
Our client is a leading organization in the field of cellular medicine, committed to advancing innovative therapies and pushing the boundaries of healthcare through cutting-edge manufacturing practices and continuous improvement.
Job Description
We are seeking a dedicated Process Improvement Specialist to join the Manufacturing Operations and - Compliance Support team within the Manufacturing Science and Technology (MSAT) department. The successful candidate will support product release, investigate root causes of deviations, and contribute to ongoing process enhancements at a facility manufacturing T-cell therapy products.
Responsibilities
- Collaborate with technical and operational teams to create, review, and update standard operating procedures (SOPs), batch records, and other operational documents.
- Lead investigations into deviations, applying root cause analysis tools to identify underlying issues.
- Develop and implement corrective and preventive actions (CAPAs) to resolve root causes and ensure long-term effectiveness.
- Support continuous improvement initiatives to optimize manufacturing processes.
- Assist with impact assessments related to product release and participate in validation activities.
- Perform additional tasks as assigned by management, supporting overall manufacturing excellence.
Requirements
- Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or a related field; engineering degrees are advantageous.
- Relevant experience in cell culture, cell therapy, or aseptic processing.
- Strong knowledge of cGMP compliance, with experience in investigating deviations, writing reports, and managing change controls.
- Excellent communication skills and ability to collaborate effectively across cross-functional teams.
- Practical understanding of scientific and engineering principles.
- Ability to adapt quickly in a fast-paced, growing environment and work independently.
- Self-motivated, detail-oriented, with strong troubleshooting skills.
Other Information
If you are interested and want to apply, please submit your application via the apply button below and contact me.
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About us
Since 2012, SIRE Life Sciences is the most innovative and engaged consultancy company for the life sciences industries.
SIRE Life Sciences is proud of its ability to adapt to changing trends while always maintaining the highest level of quality for both our clients and our candidates.
Our team of knowledgeable professionals provides customized staffing services to clients and candidates, including secondment, direct hire, temporary-to-hire, temporary staffing, brokering, Statement of Work and we approach each type with the same degree of professional assessment. Our refined and collaborative style is unmatched in the staffing industry. We’re able to see beyond the surface to create matches that result in successful careers for our candidates and valuable talent for our clients.
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