Drug Product Manufacturing Associate III

PCI Pharma Services•San Diego, CA

About The Position

The Drug Product Manufacturing Associate III executes GMP production of injectable pharmaceuticals while following 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. This associate acts as a lead in daily operations, helps ensure components are ready, operators are trained, and documentation is complete before a campaign concludes, and serves as a subject matter expert for a specific piece of equipment. The role schedules tasks and troubleshoots complex processes under the manufacturing supervisor’s oversight, supports research and implementation of improved methods and technologies, and prepares components, media, buffers, and other solutions. The position involves accurately documenting data; writing and reviewing batch records; executing and authoring SOPs and batch records; initiating revisions to GMP/SOP guidelines; and performing routine maintenance of production equipment and suites. The associate is expected to attend reliably, behave professionally, align daily work with company values and department goals, and support a safe and environmentally sustainable workplace by following EHS policies and procedures. The work requires extended periods of standing, frequent lifting of up to 50 pounds, close and distant visual focus with hand-eye coordination, and constant performance of duties while wearing aseptic gowning. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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.
Able to stand constantly for extended periods, up to four hours at a time.
Frequently able to lift up to 50 pounds.
Able to perform duties while constantly wearing aseptic gowning.

Nice To Haves

Bachelor’s degree in a science or engineering discipline preferred.

Responsibilities

Perform semi-routine manufacturing tasks according to established SOPs and cGMP regulations.
Lead daily operations by ensuring components are in place, operators are trained, and documentation is complete before a campaign is finished.
Serve as the 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 well-defined SOPs and manufacturing batch records; initiate and write revisions to current GMP/SOP guidelines.
Perform routine maintenance of production equipment and production suites.
Maintain regular and reliable attendance on a full-time basis or in accordance with the posted schedule.
Exhibit professional behavior with internal and external business associates consistent with company policies and practices.
Align daily actions with PCI Pharma Services’ cultural values, department goals, and company culture.
Follow PCI EHS policies and procedures to foster a safe and environmentally sustainable workplace.