Drug Product Manufacturing Associate I - 2nd Shift

PCI Pharma Services•San Diego, CA

3d•Onsite

About The Position

The Manufacturing Associate I executes GMP production of injectable pharmaceuticals by 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. The position works in a clean-room environment at PCI Pharma Services’ San Diego location. The 2nd shift generally runs Monday through Friday, 2:00 PM to 10:30 PM, and is eligible for a 10% pay differential when working those hours. The associate trains in one or more areas of aseptic injectable pharmaceutical manufacturing in an FDA-regulated facility, completes required SOP training, performs routine manufacturing tasks on complex equipment, documents data and batch records, and handles lab waste according to procedure. Employees are expected to attend reliably, act professionally with internal and external business associates, and align daily actions with department goals and company culture.

Requirements

High school diploma required.
Zero to two years of relevant experience in manufacturing, laboratory, mechanical, or engineering positions.
Ability to follow instructions with direct supervision.
Detail-oriented, with strong written and verbal communication skills.
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.

Nice To Haves

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

Responsibilities

Train in one or more areas of aseptic injectable pharmaceutical manufacturing using GMPs in an FDA-regulated facility.
Complete required SOP training and the training curriculum.
Prepare materials needed for aseptic operations.
Perform routine manufacturing tasks on complex equipment under established SOPs and cGMP regulations.
Accurately document data and complete batch records as needed.
Reliably execute well-defined SOPs.
Operate in clean-room environments in accordance with established policies and procedures.
Collect and dispose of lab waste according to established procedures.
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 department goals and PCI Pharma Services’ culture.