Drug Product Manufacturing Associate II

• Execute GMP production of injectable pharmaceuticals by following all applicable SOP's
• Prepare equipment and materials for GMP aseptic production
• Operate equipment such as glasswashers, autoclaves, depyrogenation ovens and automated filling machines
• Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMP's in FDA regulated facility
• Assist technical personnel with troubleshooting mechanical issues that arise with manufacturing equipment
• Perform various semi-routine manufacturing tasks under the guidelines of established SOP’s and cGMP regulations
• Troubleshoot manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management
• Assist in the research and implementation of new methods and technologies to enhance operations
• Prepare components, media, buffers, and other solutions as needed
• Accurately document data and write/review batch records under cGMP guidelines
• Prepare material components for production
• Exhibit 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
• Embody PCI Pharma Service’s cultural values and align 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
• Ability to constantly perform duties while donning aseptic gowning
• Ability to constantly sit and reach to use computers and other office equipment
• Ability to constantly stand for extended periods of time, up to four (4) hours/time
• Ability to frequently lift up to 50 pounds
• Ability to constantly view objects at close and distant ranges with hand and eye coordination
• Ability to frequently communicate with others

Bachelors in a science or engineering discipline

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