Drug Product Manufacturing Associate II - 2nd Shift

The Manufacturing Associate II is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOP's. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such from glasswashers, autoclaves, depyrogenation ovens and automated filling machines.

Responsibilities

Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility; Assists technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment; Performs various semi-routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations; Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management; Assists in the research and implementation of new methods and technologies to enhance operations; Prepares components, media, buffers, and other solutions as needed; Accurately documents data and writes/reviews batch records under cGMP guidelines; Prepares material components for production; Regular and reliable attendance on a full time basis [or in accordance with posted schedule]; Responsible for exhibiting professional behavior with both internal and external business associates that reflects positively on the company and is consistent with the company’s policies and practices; Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture

Requirements

High school diploma required; Minimum of two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions; Ability to work with cross functional teams; Detail oriented with strong written and verbal communication skills; Ability to work independently, within prescribed guidelines, or as a team member; Demonstrated ability to follow detailed directions in a manufacturing GMP environment; Familiarity with cGMP, manufacturing, machine operations, and data entry; Must be familiar with Microsoft Office applications

Nice to have

Bachelors in a science or engineering discipline preferred

Benefits

Eligibility for an annual performance bonus; Paid time off; Health insurance coverage (including dental and vision); Flexible spending account; 401(k) plan