Spclst, Engineering

Process Operations Specialist – Merck

Oversee GMP bioreactor operations for clinical manufacturing campaigns, ensuring consistent execution of upstream processes, compliance with regulatory standards, and integration with other process areas.

• Execute GMP batch records for upstream bioreactor operations across scales ranging from benchtop to 2000 L 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.

• Bachelor’s degree in biology, biotechnology, chemical engineering, or related field with a minimum of 2 years of relevant experience.
• Master’s degree with a minimum of 1 year of relevant experience.

• Hands‑on experience with bioreactor operations.

• Experience with Delta
  
  V and/or Unicorn control systems.
• 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.

• 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, biochemistry, cGMP guidelines, chemical engineering, electronic batch records, GMP compliance, laboratory experiments, mammalian cell culture, occupational health and safety management, pilot plant operations, process design, process engineering, process optimization, product formulation, safety standards, standard operating procedure writing, sterile manufacturing, teamwork.

Effective September 5, 2023, employees in office‑based positions in the U.S. will work a hybrid model of three total days on site per week, Monday‑Thursday, with Friday designated as a remote‑working day. The model does not apply to field‑based, facility‑based, manufacturing‑based, or research‑based positions where work is performed at a company site.

San Francisco, CA and Los Angeles, CA – U.S. and Puerto Rico Residents Only. All qualified applicants, including those with arrest and conviction records, will be considered in accordance with local Fair Chance Ordinances.

We are an Equal Employment Opportunity Employer; we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit the EEOC.