Drug Product Manufacturing Associate II - 1st Shift

About the role

The Manufacturing Associate II at PCI is responsible for executing Good Manufacturing Practices (GMP) in a FDA-regulated facility. This role involves preparing equipment and materials for aseptic production and operating various manufacturing equipment.

Responsibilities

• Participate in one or more areas of aseptic manufacturing of injectable pharmaceuticals using GMPs in a 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 Standard Operating Procedures (SOPs) and cGMP regulations.
• Troubleshoots manufacturing processes that are semi-complex in level under cGMP guidelines and under the supervision of management.
• 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.
• Regular and reliable attendance on a full-time basis [or in accordance with posted schedule].
• Exhibits 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 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, 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.
• Familiarity with Microsoft Office applications.

Physical Demands

• Constantly perform duties while donning aseptic gowning.
• Constantly required to sit, and to reach to 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 and Benefits

The hiring rate for this position is $27.09 - $31.60 plus eligibility for an annual performance bonus. Final offer amounts are determined by multiple factors, including but not limited to specific and relevant experience, education, credentials, geography, and subject matter expertise. PCI offers full-time employees a competitive benefits package that includes paid time off, health insurance coverage (including dental and vision), a flexible spending account, and a 401(k) plan.