Drug Product Manufacturing Associate II - 2nd Shift

About the role

The Manufacturing Associate II plays a crucial role in the aseptic manufacturing of injectable pharmaceuticals in a FDA-regulated facility. This position involves preparing equipment and materials, operating various manufacturing equipment, troubleshooting semi-complex issues, and assisting in the research and implementation of new methods and technologies.

Responsibilities

• Participates in aseptic manufacturing of injectable pharmaceuticals using GMP guidelines.
• Assists technical personnel with troubleshooting mechanical issues related to manufacturing equipment.
• Performs semi-routine manufacturing tasks according to established SOPs and cGMP regulations.
• Troubleshoots semi-complex manufacturing processes under cGMP guidelines with supervision.
• Researches and implements 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.
• Ensures regular and reliable attendance on a full-time basis.
• Behaves professionally with both internal and external business associates, reflecting positively on the company and aligning with its policies and practices.
• Embraces PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture.

Qualifications

• High school diploma required.
• Bachelor’s degree in a science or engineering discipline preferred.
• 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 or as part of a team.
• 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.

Physical Demands

• Constantly performs duties while donning aseptic gowning.
• Constantly required to sit and use computers and other office equipment.
• Frequently required to lift up to 50 pounds.
• Constantly required to view objects at close and distant ranges with hand and eye coordination.
• Frequently required to communicate with others.

Pay

$27.09 - $31.60 per hour plus eligibility for an annual performance bonus.

Schedule

2nd Shift: Starts at 2:00pm

Benefits

• Paid time off
• Health insurance coverage (including dental and vision)
• A flexible spending account
• A 401(k) plan