About Our Client
Our client is a leading global biotechnology company at the forefront of advanced cell therapy manufacturing. Their commercial site specializes in the production of innovative T-cell therapies that are transforming outcomes for patients with serious and life-threatening diseases.
Operating in a highly regulated GMP environment, they combine scientific excellence, cutting-edge technology, and strong operational standards to deliver life-changing treatments. The organization offers a dynamic, fast-paced environment with strong cross-functional collaboration and a commitment to continuous improvement.
About the Position
We are seeking a Process Engineer to join the Manufacturing Operations & Compliance Support team within MSAT.
This role plays a key part in supporting commercial manufacturing by leading technical assessments, investigating deviations, and driving process improvements to ensure compliant and efficient product release.
The successful candidate will work closely with Manufacturing, Quality, and Technical teams to maintain high standards of operational excellence in a GMP-regulated cell therapy facility.
Key Responsibilities
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Support impact assessments related to product release and manufacturing performance
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Lead and coordinate deviation investigations using structured root cause analysis tools
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Develop and implement effective CAPAs to address identified root causes
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Collaborate cross-functionally to resolve technical and operational issues
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Author and revise GMP documentation including SOPs, batch records, and technical reports
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Contribute to continuous improvement initiatives and site projects
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Provide technical support within a fast-paced commercial manufacturing environment
Requirements
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Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or related field
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Experience in cell culture, cell therapy, or aseptic processing within a GMP environment
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Solid understanding of cGMP requirements and compliance standards
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Experience leading investigations, writing deviation reports, change controls, and corrective actions
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Strong analytical, troubleshooting, and problem-solving skills
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Excellent communication skills with the ability to work effectively in cross-functional teams
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Comfortable working in a dynamic and evolving environment
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Self-motivated, detail-oriented, and adaptable to shifting priorities
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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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