Merck · 4 hours ago
Spclst, Engineering
Lansdale, PA
Full-time
Hybrid
Entry, Mid Level
$86K/yr - $135K/yr
1+ years expMerck 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.
BiotechnologyHealth CareMedicalPharmaceutical
No H1B
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
Qualification
Required
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
Preferred
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
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital AdvisorsGavi, the Vaccine Alliance
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2025-12-30
2025-12-30
BioWorld Financial Watch
2025-12-29
Company data provided by crunchbase