Engineer II - MTS/MSAT

About the role

The Manufacturing Science and Technology (MST) Engineer II supports the execution of manufacturing processes in a CMO multi-product, multi-line cGMP facility capable of manufacturing commercial, clinical, and development drug products and medical devices. This role involves troubleshooting, new product implementation (tech transfer), start-up activities (process design, batch record development), compliance and regulatory/inspection support, process data analysis, and process improvement implementation.

Responsibilities

• Work with process development teams (external clients, internal project managers, and R&D) to transition products through the technology transfer timeline.
• Implement and support FDA-compliant manufacturing of medical devices and drug products.
• Collaborate with clients to deliver clinical and commercial raw materials supply requirements through process ownership, troubleshooting, and transfer of robust manufacturing processes.
• Support the processing and composition of FMEA risk assessments with cross-functional departments and integrate reliable manufacturing-scale equipment into production.
• Support technology transfer into GMP manufacturing by generating process descriptions, technology transfer documents/reports, developing and reviewing master batch records, and providing on-floor support for GMP operations.
• Evaluate unit operations used in manufacturing and support change control processes to implement new process operations.
• Troubleshoot process disturbances, identify resolutions, and implement corrective and preventive measures.
• Provide proactive, real-time support for critical operations.
• Perform process monitoring and data analysis, including real-time review of process parameters and trend analysis, and communicate process performance across departments.
• Serve as the operations subject matter expert (SME) for technology transfer and start-up of products by reviewing process parameters, site assessments, developing manufacturing batch records, and other tech transfer deliverables.
• Actively support process and product-related investigations, execute CAPAs, and provide input to process and equipment change controls.
• Anticipate potential issues by relying on prior experience and gaining new industry knowledge.
• Support and enforce company goals, policies, procedures, Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), and FDA, EU, QSR, and ISO regulations.
• Ensure resolution of technical issues to meet production demand and product release.
• Participate in the investigation of failures and implement action plans for internal corrective actions and audit findings.
• Maintain accurate documentation of concepts, designs, and processes while staying current with medical, technical, and biomedical developments.
• Provide "on-floor" manufacturing technical support to operations.
• Utilize root cause analysis to generate complete and concise investigation reports for quality discrepancies and deviations during GMP production.
• Apply knowledge of multiple engineering disciplines to evaluate and develop solutions for operational issues.
• Demonstrate proficiency with Microsoft products and the ability to learn additional applications as needed.
• Apply Quality by Design, Six Sigma, and operational excellence tools to create efficient, high-quality processes and end products.
• Understand new manufacturing technologies, including single-use disposables.

Requirements

• BS degree in an Engineering discipline, preferably Chemical or Life Sciences, with 4+ years of industry experience within a pharmaceutical, biotechnology/medical device, or FDA/ISO regulated industry. Comparable blends of education and experience are acceptable.
• Process Engineering/development experience in the biotechnology/pharmaceutical/medical device industry with expertise in scale-up, tech transfer, and manufacturing support for large-scale GMP operations.
• Familiarity with large-scale disposable technologies, devices, and production equipment for unit operations is highly preferred.
• Proven track record of large-scale process implementation.
• General understanding of fill finish, freeze drying (lyophilization), medical device, filtration, milling, mixing technologies, fluid metering, formulation, and purification.
• Knowledge of equipment in pharmaceutical manufacturing, including autoclave, filling pump, vial washer, depyrogenation oven, lyophilizers, and process utilities (WFI, PW, Clean Steam, HVAC, etc.).

Qualifications

• Resilient, able to quickly move forward despite challenges.
• Drive to achieve results while working with limited supervision.
• Positive attitude and strong team and cross-team collaboration skills.
• Honesty, integrity, respect, and courtesy with leadership and peers.
• Strong commitment to conducting business according to the highest legal and ethical standards and pursuing excellence in manufacturing and delivering products and services.