Job Description
This position is responsible for operating large‑scale manufacturing equipment to produce bulk APIs (Active Pharmaceutical Ingredients) in accordance with company standards and operating procedures. The employee will maintain detailed operating reports and batch records, ensure compliance with cGMP and OSHA regulations, and handle equipment such as reaction vessels, crystallizers, centrifuges, filters, evaporators, heat exchangers, pumps, valves, and other equipment.
Responsibilities
- Operate and monitor reaction vessels, crystallizers, centrifuges, filters, evaporators, heat exchangers, pumps, valves, and other equipment through manual operations, panel boards, indicators, and HMI displays.
- Operate and monitor hoists, dryers, mills, sifters, dust collectors, blowers, packaging stations, and other equipment through manual operations, panel boards, indicators, and HMI displays.
- Package, weigh, sample, and label finished goods and intermediate products following batch records, procedures, and good documentation practices.
- Maintain detailed operating reports and batch records, including notes on problems and records on added weights, volumes, measured temperatures, pH levels, pressures, and flow rates.
- Operate forklifts, hoists, and other material‑handling devices to move bulk raw materials, WIP, and packaged goods.
- Deliver samples to the laboratory and retrieve operating supplies from storerooms.
- Monitor environmental and safety devices (scrubbers, rupture discs, relief valves, etc.) to ensure equipment functions properly.
- Clean and maintain work area, process equipment, tools, and safety supplies according to regulatory and company standards.
- Participate in employee involvement teams and committees, such as Area/Site Safety Teams, Kaizen events, and Cost Savings Teams.
- Perform Lock Out/Tag Out (LOTO) independently using a personal lock.
- Complete other duties as assigned by management.
Qualifications
- High School Diploma, GED, or equivalent required.
- Previous GMP manufacturing experience preferred.
- Ability to communicate effectively in both verbal and written formats.
- Ability to read and follow detailed instructions and procedures.
- Basic math skills.
- Working knowledge of chemical and/or powder processing equipment and associated safety requirements.
- Sound problem‑solving and decision‑making skills.
- Ability to work in a team environment and cover workstations during breaks and lunches.
Leadership Responsibilities
No direct responsibility for the work of others.
Work Conditions
- Must wear required PPE, including hard hat, safety glasses, ear plugs, steel‑toe boots, gloves, chemical‑resistant aprons and suits, and other necessary equipment.
- Must be able to lift and carry up to 50 pounds and use material‑handling devices such as hand trucks, fork trucks, and conveyors.
- Must be physically able to climb stairs and ladders, roll drums, lift and pour bags of raw materials, and drive forklifts.
- Must be able to work in outdoor conditions as portions of the facility are not climate‑controlled.
- Must be able to work rotating 12‑hour shifts and overtime as needed.
EEO Statement
We comply with all applicable federal, state, and local laws prohibiting discrimination and harassment, and provide equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, disability, veteran status, genetic information, or any other classification protected by federal, state or local law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.