Drug Product Manufacturing Associate II

• 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

• 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
• Constantly perform duties while donning aseptic gowning
• Constantly required to sit, and to reach to use computers and other office equipment
• Constantly stand for extended periods of time, up to four (4) hours/time
• 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

Bachelors in a science or engineering discipline preferred

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