Spclst, Engineering
Merck is a leading global biopharmaceutical company dedicated to discovering and developing innovative medicines. The Process Operations Specialist is responsible for leading and executing GMP bioreactor operations to support clinical manufacturing campaigns, ensuring compliance and high-quality biomanufacturing operations.
Responsibilities
- Execute GMP batch records for upstream bioreactor operations across scales ranging from benchtop to 2000L in stainless steel, glass, and single-use systems
- Lead small teams in the preparation, setup, operation, and teardown of bioreactors and associated support systems
- Perform in-process monitoring, sampling, and real-time data review to ensure process performance and compliance
- Troubleshoot process and equipment issues, collaborating with engineering, process development, and quality functions to resolve deviations and maintain production flow
- Support new process introduction, scale-up activities, and technical transfer into GMP operations
- Maintain and complete GMP documentation, including batch records, logbooks, and deviation reports in compliance with regulatory and site standards
- Promote a strong safety culture and adherence to environmental, health and safety procedures
- Participate in continuous improvement initiatives focused on process robustness, equipment reliability, and operational efficiency
- Train and mentor less-experienced staff in GMP operations, equipment use, and documentation practices
Skills
- Bachelor's degree in biology, biotechnology, chemical engineering, or related field with a minimum of 2 years of relevant experience, or
- Master's degree with a minimum of 1 year of relevant experience
- Hands-on experience with bioreactor operations
- Execute GMP batch records for upstream bioreactor operations across scales ranging from benchtop to 2000L in stainless steel, glass, and single-use systems
- Lead small teams in the preparation, setup, operation, and teardown of bioreactors and associated support systems
- Perform in-process monitoring, sampling, and real-time data review to ensure process performance and compliance
- Troubleshoot process and equipment issues, collaborating with engineering, process development, and quality functions to resolve deviations and maintain production flow
- Support new process introduction, scale-up activities, and technical transfer into GMP operations
- Maintain and complete GMP documentation, including batch records, logbooks, and deviation reports in compliance with regulatory and site standards
- Promote a strong safety culture and adherence to environmental, health and safety procedures
- Participate in continuous improvement initiatives focused on process robustness, equipment reliability, and operational efficiency
- Train and mentor less-experienced staff in GMP operations, equipment use, and documentation practices
- Strong ownership and accountability for assigned tasks and team outcomes
- Ability to work effectively in a team-based matrixed environment
- Flexible and adaptable to changing priorities, including off-shift work as needed
- Excellent attention to detail, communication, and documentation skills
- Commitment to maintaining the highest standards of safety, quality, and compliance
- Adaptability
- Aseptic Technique
- Biomanufacturing
- Biotechnology
- CGMP Guidelines
- Chemical Biology
- Chemical Engineering
- Chemical Technology
- Electronic Batch Records
- GMP Compliance
- Laboratory Experiments
- Mammalian Cell Culture
- Occupational Health and Safety Management
- Personal Initiative
- Pilot Plant Operations
- Process Design
- Process Engineering
- Process Optimization
- Product Formulation
- Safety Standards
- Standard Operating Procedure (SOP) Writing
- Standards Compliance
- Sterile Manufacturing
- Teamwork
- Experience with DeltaV and/or Unicorn control systems strongly preferred
- Working knowledge of GMP documentation, deviation management, and aseptic technique
- Familiarity with upstream and downstream unit operations in biopharmaceutical manufacturing
- Proven ability to lead teams
Benefits
- Medical
- Dental
- Vision healthcare
- Other insurance benefits (for employee and family)
- Retirement benefits, including 401(k)
- Paid holidays
- Vacation
- Compassionate and sick days
Company Overview