Drug Product Manufacturing Associate III
About The Position
The Drug Product Manufacturing Associate III executes GMP production of injectable pharmaceuticals in accordance with applicable SOPs. The role prepares equipment and materials for GMP aseptic production and operates equipment such as glasswashers, autoclaves, depyrogenation ovens, and automated filling machines. The associate performs semi-routine manufacturing tasks, leads daily operations, serves as a subject matter expert for specific equipment, and schedules and troubleshoots manufacturing work under the supervision or oversight of the manufacturing supervisor. The position also supports process improvements, prepares production components and solutions, maintains equipment and production suites, and accurately documents work in batch records and SOPs. The role requires regular and reliable full-time attendance, professional conduct, alignment with company and department values, and adherence to environmental health and safety policies. Work involves extended standing, aseptic gowning, frequent communication and visual coordination, and lifting up to 50 pounds.
Requirements
- High school diploma required.
- Minimum of four years of related work experience in manufacturing, laboratory, mechanical, or engineering positions.
- Demonstrated ability to follow detailed directions in a manufacturing GMP environment.
- Familiarity with cGMP, manufacturing, machine operations, and data entry.
- Familiarity with Microsoft Office applications.
- Ability to stand for extended periods, up to four hours at a time; lift up to 50 pounds; perform duties while wearing aseptic gowning; and communicate and coordinate hand and eye activities.
Nice To Haves
- Bachelor’s degree in a science or engineering discipline preferred.
Responsibilities
- Perform semi-routine manufacturing tasks under established SOPs and cGMP regulations.
- Lead daily operations by ensuring components are available, operators are trained, and documentation is complete before a campaign is finished.
- Serve as a subject matter expert for a specific piece of equipment.
- Schedule manufacturing tasks in accordance with cGMP guidelines under close supervision of the manufacturing supervisor.
- Troubleshoot complex manufacturing processes under cGMP guidelines with oversight from the manufacturing supervisor.
- Assist in researching and implementing methods and technologies to enhance operations.
- Prepare components, media, buffers, and other solutions as needed.
- Accurately document data and write or review batch records in compliance with cGMP guidelines.
- Execute and author SOPs and manufacturing batch records, and initiate and write revisions to current GMP/SOP guidelines.
- Perform routine maintenance of production equipment and production suites.
- Exhibit professional behavior with internal and external business associates consistent with company policies and practices.
- Align daily actions with department goals and company culture.
- Follow PCI environmental health and safety policies and procedures to foster a safe and environmentally sustainable workplace.
- Maintain regular and reliable attendance on a full-time basis or according to the posted schedule.
Benefits
- Paid time off
- Health insurance coverage, including dental and vision
- Flexible spending account
- 401(k) plan
- Eligibility for an annual performance bonus
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
High school or GED
