Our Team/ Overview
The Manufacturing team is expanding and seeking an Engineer, Manufacturing to serve as the technical process and system owner for Central Manufacturing Services (CMS), driving continuous improvement, change management, and operational reliability across CMS processes and equipment.
The Engineer, Manufacturing will own the technical integrity and optimization of CMS processes - including Media and Buffer preparation, Autoclave operations, Column Packing, and Automated Logistics - ensuring these operate consistently within defined parameters, remain compliant with GMP requirements, and deliver measurable improvements in robustness, cost efficiency, and operational performance.
The Engineer will work closely with MSAT, Quality, Automation, and other cross-functional teams to identify opportunities, drive change controls, resolve technical issues, and champion a culture of continuous improvement within CMS.
This position reports to the Senior Manager, Manufacturing.
Main Accountabilities
1.CMS Process & System Ownership
- Own the technical integrity and performance of assigned CMS processes and equipment systems.
- Maintain deep process knowledge and serve as the technical subject matter expert (SME) for CMS operations, supporting troubleshooting and technical decision-making.
- Monitor process performance data, trends, and key indicators analyze patterns to identify opportunities for improvement or early warning signs of drift.
- Support process parameter definition, control limits, and acceptance criteria to ensure robust, repeatable operations.
2. Continuous Improvement& Change Leadership
- Proactively identify and drive continuous improvement initiatives across CMS processes, targeting measurable outcomes in cost reduction, cycle time savings, process robustness, and operational efficiency.
- Author, lead, and manage change controls to implement process improvements, equipment modifications, procedural enhancements, or system upgrades.
- Apply Lean, OE, and Six Sigma methodologies to eliminate waste, reduce variability, and optimize CMS workflows (e.g., Media & Buffer preparation cycle times, autoclave turnaround, logistics flow optimization).
- Track and report improvement project outcomes with clear metrics - cost savings, time savings, yield improvements, or deviation reduction.
- Collaborate with MSAT and Automation teams to leverage digital tools, process data analytics, and automation capabilities to enhance process control and efficiency.
3. Equipment & Process Reliability
- Drive initiatives to improve the consistency, reliability, and control of CMS equipment and processes, reducing variability and deviation risk.
- Lead or support equipment reliability and asset care improvements, including preventive maintenance optimization and equipment performance monitoring.
- Conduct and lead process risk assessments (e.g., FMEA) to proactively identify and mitigate operational risks within CMS.
- Support equipment qualification, validation, and periodic reviews to ensure continued fitness for purpose.
- Identify and recommend equipment or process upgrades to enhance reliability, reduce downtime, or improve efficiency.
4. Deviation & Investigation Support
- Lead technical investigation and root cause analysis of CMS-related process deviations, equipment failures, or performance issues.
- Develop and drive effective, sustainable corrective actions (CAPAs) to prevent recurrence and improve process robustness.
- Ensure deviations are closed in a timely manner with robust technical solutions.
- Track CAPA effectiveness and report outcomes to the Senior Manager, Manufacturing.
5. GMP, Safety & Compliance
- Ensure all CMS technical activities and documentation are performed in full compliance with GMP, EHS, and site requirements.
- Support audit and inspection readiness for CMS, ensuring technical documentation, process controls, and system validation are consistently inspection ready.
- Maintain data integrity and traceability across CMS process documentation and change records.
6. Support to New Product Introduction (NPI) & Startup (As Required)
- Provide technical process expertise to NPI and process startup activities within CMS scope as assigned.
- Contribute to process risk assessments and readiness reviews for new CMS processes or equipment.
- Support process data collection, verification, and documentation during engineering runs or startup manufacturing.
7. Cross-Functional Collaboration
- Work closely with Manufacturing Operations to understand operational challenges and translate them into technical improvements.
- Collaborate with Quality, MSAT, and Automation teams to align on process improvements, data analytics, and system enhancements.
- Engage with Equipment vendors and engineering teams to support troubleshooting, optimization, and system upgrades.
Knowledge, Skills &Competencies
- Strong technical understanding of CMS processes, including Media and Buffer preparation, Autoclave operations, Column Packing, and Automated Logistics systems.
- Demonstrated ability to drive change and lead improvement projects with measurable outcomes (cost savings, time savings, deviation reduction).
- Proficient in data analysis and process trending to support performance monitoring and improvement decision-making.
- Working knowledge of GMP requirements, change control processes, and data integrity principles.
- Experienced in deviation investigation and root cause analysis methodologies (e.g., Fishbone, 5-Why, Fault Tree Analysis).
- Familiarity with Lean, OE, or Six Sigma tools and methodologies.
- Strong technical problem-solving and analytical thinking skills.
- Excellent technical writing and communication skills, with the ability to engage and influence cross-functional stakeholders.
- Strong team player with a proactive, continuous improvement mindset.
Qualifications / Requirements
- Diploma or Bachelor's degree in Biotechnology, Biochemical Engineering, Chemical Engineering, Life Sciences, or a related discipline.
- 3-5 years of experience in biopharmaceutical manufacturing operations, process engineering, or technical support in a regulated GMP environment, with demonstrated experience in CMS or related support functions.
- Proven track record of leading or contributing to continuous improvement, change control, or process optimization initiatives with measurable outcomes.
- Experience with process data analysis, Single use Systems, deviation investigation, or equipment troubleshooting is advantageous.
