Scientific Manufacturing Operator

Cambrex - Charles City

Charles City (IA)

On-site

USD 42,000 - 62,000

Full time

7 days ago
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Job summary

Cambrex - Charles City in Iowa seeks a Scientific Manufacturing Operator to safely operate and monitor pharmaceutical manufacturing equipment for APIs and intermediates in a cGMP environment. The role blends scientific knowledge with hands-on manufacturing, offering a career-entry path for graduates to gain API production experience.

The position emphasizes operating reactors, monitoring variables, performing in-process testing, maintaining records, and supporting continuous improvement

Qualifications

  • Bachelor's degree in Chemistry or related scientific field.
  • 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 in a highly regulated pharmaceutical manufacturing environment.

Responsibilities

  • Operate batch and continuous reactors and related equipment.
  • Monitor process variables and ensure SOPs and cGMP compliance.
  • Utilize control systems and manufacturing software to oversee production.
  • Perform in-process sampling and analytical testing to monitor quality.
  • Interpret data and adjust operations within approved parameters.
  • Maintain accurate production records, logs, and documentation.

Job description

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 escape 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

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.

Equal employment opportunity, including veterans and individuals with disabilities.

PI287236220

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