About the Company
A leading cell therapy company is expanding its Manufacturing Operations and Compliance Support (MOCS) team at its commercial T-cell therapy production site. The team ensures technical operations run efficiently while maintaining compliance with current Good Manufacturing Practice (cGMP) standards and supports product release, continuous improvement, and operational excellence.
Role Description
As a Process Engineer within the MSAT department, you will provide technical support for commercial manufacturing of T-cell therapy products. You will be responsible for root-cause investigations, impact assessments, continuous improvement initiatives, and compliance-related projects. This role requires strong technical knowledge, attention to detail, and the ability to work collaboratively across functions in a fast-paced environment.
Key Responsibilities
- Collaborate with technical and operational stakeholders to write, review, and revise SOPs, batch records, and other operational documents
- Investigate deviations and coordinate resolutions using root-cause analysis tools
- Develop, implement, and follow up on CAPAs to address deviations and ensure effectiveness
- Support continuous improvement initiatives and process optimization projects
- Perform impact assessments to support product release
- Take on additional tasks or temporary responsibilities as assigned by management
Requirements
- Bachelor’s degree in Biochemical Engineering, Chemical Engineering, Biotechnology, or equivalent (Engineering degree is a strong plus)
- Experience in cell culture, cell therapy, and/or aseptic processing
- Proven technical knowledge of cGMP compliance, including deviation investigations, change controls, and corrective actions
- Excellent communication and collaboration skills in cross-functional teams
- Strong scientific and engineering understanding
- Ability to work independently in a fast-paced and changing environment
- Self-motivated, detail-oriented, and flexible to take on temporary responsibilities
- Critical thinking, troubleshooting, and problem-solving skills
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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.
Effective employment solutions need to put the right person in the relevant place every time, using advanced systems to streamline costs and time-frames for clients.