Drug Product Manufacturing Associate II - 1st Shift

Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

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Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The Manufacturing Associate II is responsible for executing GMP production of injectable pharmaceuticals by following all applicable SOPs. Manufacturing associates are responsible for preparing equipment and materials for GMP aseptic production and operating equipment such as glass washers, autoclaves, depyrogenation ovens and automated filling machines.

• Participate in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMPs 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 SOPs 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.

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• High school diploma required. Bachelors 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.
• Must be familiar with Microsoft Office applications.

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties the employee is:

• 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.
• 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.

Note:

For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the work day, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

* The hiring rate for this position is $24.00-$30.00 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.

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