updated 1 month ago
Senior Process Engineer, MSAT (CGT)
Vacancy from Hirify Global, list of international tech companiesPlus is required to make matches and apply
Match & Cover letter
Plus required for matching with this vacancy
Job description
Text:
TL;DR
Senior Process Engineer, MSAT (CGT) (Cell and Gene Therapy): Supporting the transfer, scale-up, validation, troubleshooting, and optimization of customer manufacturing processes in a GMP aseptic manufacturing environment with an accent on technology transfer, process compliance, and technical documentation. Focus on conducting lab-scale experiments, monitoring production campaigns, managing change controls, and supporting audits and regulatory inspections.
Location: Tuas, Singapore
Company
is a global life sciences contract manufacturer providing manufacturing services and technology platforms for biologics, pharmaceuticals, and cell and gene therapies.
What you will do
- Lead or support technology transfer and scale-up of customer manufacturing processes.
- Collaborate with global teams, vendors, and customers to implement transferred processes successfully.
- Conduct lab-scale experiments, troubleshoot process issues, and drive process optimization.
- Author and review technical documentation and training materials.
- Monitor production runs, provide on-floor campaign support, ensure GMP compliance, and manage change controls.
- Participate in audits and regulatory inspections.
Requirements
- Degree in science or engineering.
- 5–10 years of experience in process development or life sciences.
- Deep knowledge of cell and gene therapy, GMP, and aseptic manufacturing.
- Strong collaboration and communication skills with clients and internal teams.
Nice to have
- Experience with material assessment and continuous improvement projects.
- Experience serving as a subject-matter expert for materials-related investigations and global discussions.
- Experience managing quality events such as CRFs, nonconformances, and CAPAs.
- Knowledge of advances in cell and gene therapy materials and experience mentoring team members.
Culture & Benefits
- Exposure to biotech and established pharmaceutical customers.
- Opportunity to work with manufacturing technologies for mammalian treatments and cell therapies.
- Participation in a global manufacturing network focused on reliable, high-quality, and compliant services.
- Work centered on ethical scientific problem-solving and developing ideas that improve patient lives.
Be careful: if the employer asks you to log into their system using iCloud/Google, send codes/passwords, or run code/software, don't do it - these are scammers. Always click "Report" or contact support. More in guide →