Company Information You Matter to Cambrex. Cambrex is a leading global contract development and manufacturing organization (CDMO) that provides drug substance development and manufacturing across the entire drug lifecycle, as well as comprehensive analytical and IND enabling services. With over 40 years of experience and a team of 2,000 experts servicing global clients from North America and Europe, Cambrex offers a range of specialized drug substance technologies and capabilities, including continuous flow, controlled substances, liquid-phase peptide synthesis, solid-state science, material characterization, and highly potent APIs. Your Work Matters. At Cambrex, we strive to build a culture where all colleagues have the opportunity to: engage in work that matters to our customers and the patients they serve learn new skills and enjoy new experiences in an engaging and safe environment strengthen connections with coworkers and the community We’re committed to attracting and nurturing a passionate team of valued professionals in our fast-paced and growing company. We offer a competitive benefits package that includes healthcare, life insurance, planning for retirement, and more! Your Future Matters. Known for our customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities across our global network of locations. Together with our customers, we aim to improve the quality of life for patients around the world. Start a career where You Matter by applying today! Job 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. Education, Experience & Licensing Requirements 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. Ability to stand and walk for extended periods throughout assigned shifts. Ability to lift, move, and handle materials weighing up to 50 pounds. Ability to regularly climb stairs, bend, reach, stoop, and move throughout a manufacturing facility. Ability to wear required personal protective equipment (PPE), including steel-toe shoes, safety glasses, hearing protection, respirators, and flame-resistant clothing, as required. Ability to work in a production environment with potential exposure to chemicals, solvents, powders, dust, odors, noise, fumes, and varying temperatures. Ability to work nights, weekends, holidays, overtime, and rotating schedules based on business needs. Cambrex is committed to providing a safe and productive work environment. All offers of employment are contingent on the successful completion of a comprehensive pre-employment screen. The pre-employment screen may consist of several components including but not limited to a drug test, criminal record check, identity verification, reference checks, education and employment verification, and may vary based on federal, state, and local laws. Refusal to submit to testing will result in disqualification of further employment consideration. All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities. Cambrex Corporation is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, sex (including pregnancy, sexual orientation, or gender identity), ancestry, national origin, place of birth, age, marital status, disability/handicap, genetic information, veteran status, or other characteristics protected by federal, state, and/or local law. 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. 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.
