Drug Product Manufacturing Associate III

About the role

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

We are PCI.

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 Drug Product Manufacturing Associate III is responsible for executing GMP production of injectable pharmaceuticals while following all applicable SOPs. This role includes preparing equipment and materials for GMP aseptic production and operating equipment such as glasswashers, autoclaves, depyrogenation ovens and automated filling machines.

Essential Duties and Responsibilities

• Perform various semi-routine manufacturing tasks under the guidelines of established SOPs and cGMP regulations.
• Act as a lead in daily operations, ensuring all components are in place, operators are trained, and all documentation is complete prior to finishing a campaign.
• Serve as a subject matter expert for a specific piece of equipment.
• Schedule manufacturing tasks in accordance with cGMP guidelines under the close supervision of the manufacturing supervisor.
• Troubleshoot complex manufacturing processes under cGMP guidelines with oversight from the manufacturing supervisor.
• Assists in researching and implementing new methods and technologies to enhance operations.
• Prepare components, media, buffers, and other solutions as needed.
• Accurately document data and write/review batch records in compliance with cGMP guidelines.
• Reliably execute and author well defined SOPs and manufacturing batch records; initiate and write revisions to current GMP/SOP guidelines.
• Perform routine maintenance of production equipment and production suites.
• 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.
• Foster a safe and environmentally sustainable workplace by following all PCI EHS policies and procedures

While performing the duties the employee is

• occasionally 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.
• requently 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
• constantly performs duties while donning aseptic gowning.
• Note: For the purpose of this summary, occasionally is used to represent up to 1/3 of the time given to the workday, frequently represents 1/3 to 2/3 of the time and constantly represents 2/3 or more of the time.

Qualifications

• High School Diploma required; bachelors in a science or engineering discipline preferred.
• Minimum of four (4) years of related work experience in manufacturing, laboratory, mechanical or engineering positions.
• 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 hiring rate for this position is $33.36 -$38.92 per hour 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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