Drug Product Manufacturing Associate I - 2nd Shift

About the role

The Manufacturing Associate I plays a crucial role in the execution of Good Manufacturing Practices (GMP) for injectable pharmaceuticals within a FDA-regulated facility. This position involves preparing equipment and materials for aseptic operations, operating various pieces of equipment, and adhering to strict SOPs and cGMP regulations.

Responsibilities

• Train in one or more areas of aseptic manufacturing of injectable pharmaceuticals using GMPs in a FDA-regulated facility.
• Execute training curriculum and prepare materials needed for aseptic operations.
• Operate equipment such as glasswashers, autoclaves, depyrogenation ovens, and automated filling machines.
• Accurately document data and complete batch records as needed.
• Operate in clean room environments in compliance with established policies and procedures.
• Collect and dispose of lab wastes according to established procedures.
• Reliably execute well-defined SOPs.
• Communicate effectively with others while maintaining professional behavior.
• Embody PCI Pharma Service’s cultural values and align 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 zero to two (2) years of relevant experience in manufacturing, laboratory, mechanical, or engineering positions.
• 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.

Physical Demands

• Sit and reach to use computers and other office equipment.
• Occasionally stand for extended periods of time, up to four (4) hours/time.
• Lift up to 40 pounds.
• View objects at close and distant ranges.
• Communicate with others frequently.

Benefits

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