Scientific Manufacturing Operator

Overview:

Reporting to the Shift Supervisor, the Scientific Manufacturing Operator is responsible for safely operating and monitoring pharmaceutical manufacturing equipment used in the production of active pharmaceutical ingredients (APIs) and pharmaceutical intermediates. This role combines scientific knowledge with hands-on manufacturing operations in a current Good Manufacturing Practice (cGMP)-regulated environment.

The Scientific Manufacturing Operator will operate reactors and supporting process equipment, perform in-process testing, monitor production parameters, troubleshoot equipment and process issues, and ensure all activities are documented in accordance with cGMP requirements.

This is a career-entry scientific manufacturing role that provides recent graduates with an opportunity to apply their scientific or engineering education in a large-scale pharmaceutical manufacturing environment while developing technical expertise in API manufacturing processes.

Responsibilities:

• Operate batch and continuous reactors, centrifuges, filters, solvent distillation equipment, dryers, and supporting process equipment in accordance with approved procedures.
• Execute manufacturing activities in accordance with batch records, standard operating procedures (SOPs), safety requirements, and cGMP regulations.
• Monitor and control process variables, including temperatures, pressures, flows, vacuum systems, reaction conditions, and other critical process parameters.
• Utilize computerized control systems and manufacturing software to monitor and operate pharmaceutical production processes.
• Perform routine in-process sampling and analytical testing to monitor production quality and process performance.
• Interpret analytical and process data and make appropriate operational adjustments within established procedures and operating parameters.
• Troubleshoot equipment and process issues in a safe and effective manner and escalate issues as appropriate.
• Complete equipment setup, cleaning, inspection, and changeover activities in accordance with approved procedures.
• Assist with the implementation of new manufacturing processes, process improvements, technology transfers, and validation activities.
• Support production investigations, deviation investigations, root cause analyses, and continuous improvement initiatives.
• Maintain accurate production records, batch documentation, equipment logs, and electronic records in compliance with cGMP requirements and data integrity standards.
• Assist in writing, reviewing, and updating manufacturing procedures, SOPs, batch records, and other production documentation.
• Safely handle, transfer, package, and inventory raw materials, intermediates, and finished products.
• Support environmental, health, and safety initiatives while maintaining compliance with all applicable regulations and company policies.
• Participate in required training activities and support the onboarding and training of new operators as directed.
• Work collaboratively with Quality Assurance, Quality Control, Engineering, Maintenance, Technical Services, Supply Chain, and Manufacturing teams to support operational objectives.
• Maintain a clean, organized, and inspection-ready work environment.
• Perform other duties and special projects as assigned.

Qualifications / Skills::

• Strong problem-solving and critical-thinking skills.
• Ability to learn, understand, and apply chemical and pharmaceutical manufacturing processes.
• Strong written and verbal communication skills.
• Mechanical aptitude and technical troubleshooting ability.
• Ability to interpret analytical and process data and make appropriate operational decisions.
• Strong attention to detail and commitment to documentation accuracy.
• Ability to work effectively in a team-based environment.
• Ability to follow detailed manufacturing procedures, batch records, and technical instructions.
• Proficiency with computerized manufacturing systems and Microsoft Office applications.
• Commitment to safety, quality, regulatory compliance, and continuous improvement.

Qualifications:

 

Required

• Bachelor's degree in Chemistry, Biochemistry, Chemical Engineering, Biology, Biotechnology, Pharmaceutical Sciences, Industrial Technology, Microbiology, Engineering, or another related scientific or engineering discipline.
• Ability to understand and apply scientific and technical principles within a manufacturing environment.
• Strong analytical, organizational, critical-thinking, and problem-solving skills.
• Ability to work safely and effectively in a highly regulated pharmaceutical manufacturing environment.

Preferred

• Internship, co-op, laboratory, academic research, manufacturing, or industrial experience.
• Experience working in a regulated environment such as pharmaceutical, biotechnology, food, chemical, or medical device manufacturing.
• Familiarity with cGMP, FDA, EPA, OSHA, or other applicable regulatory requirements.
• Experience with process equipment, laboratory instrumentation, computerized control systems, or manufacturing software.