Join a dynamic team and play a critical role in supporting day-to-day manufacturing operations and capital project implementation. Reporting to the Operations Manager, you will be responsible for troubleshooting processes, optimizing manufacturing systems, and ensuring compliance with cGMP and EHS standards.
The role will be an upstream manufacturing process specialist who will have responsibility for the day to day production of our products, act as a point of contact for a product (product owner), trending of process parameters and managing non-conformances.
Hybrid: 3 dyas/week on-site
Key Responsibilities:
- Represent Operations on cross-functional project teams to ensure seamless execution.
- Troubleshoot and optimize manufacturing processes, equipment, and DCS/PLC systems.
- Monitor and report process performance using statistical tools.
- Lead and support commissioning, qualification, and validation activities.
- Investigate and resolve manufacturing issues while driving continuous improvement initiatives.
- Develop and maintain batch records, procedures, and work instructions.
- Provide process training and mentorship to team members.
What We're Looking For:
- Degree in Microbiology, Biochemistry, Biotechnology, Engineering, or related fields.
- 5+ years experience hands-on experience OR Validation experience in GMP-regulated environments, cell culture, or purification processes.
- Upstream Bioreactors experience.
- Proficiency in Delta V, SCADA, SAP, or similar systems.
- Strong problem-solving skills with Six Sigma or similar methodology experience (preferred).
- Excellent interpersonal, communication, and team collaboration abilities.
This is an exciting opportunity for someone with a passion for operational excellence, problem-solving, and collaboration in the production of cutting-edge biopharmaceuticals.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.
