The Process Operations Specialist is responsible for leading and executing GMP bioreactor operations in support of clinical manufacturing campaigns, ensuring consistent execution of upstream processes and supporting integration with other process areas

• The Specialist applies technical knowledge, problem solving and leadership skills to deliver high-quality, compliant biomanufacturing 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

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely

• Master’s degree with a minimum of 1 year of relevant experience
• Hands-on experience with bioreactor operations
• 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

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

Adaptability, 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 {+ 2 more}

$85,600.00 - $134,800.00 An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs

• The successful candidate will be eligible for annual bonus and long-term incentive, if applicable
• We offer a comprehensive package of benefits
• Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days
• More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits

No relocation