Drug Product Manufacturing Associate II - 1st Shift
PCI Pharma Services
Summary
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 glasswashers, autoclaves, depyrogenation ovens and automated filling machines.
Job description
Essential Duties and Responsibilities
- 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.
- 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.
Qualifications
- 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.
Physical Demands
- 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.
Requirements
- 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
Benefits
- Paid Time Off
- Health Insurance
- Dental Insurance
- Vision Insurance
- Flexible Spending Account
- 401(k) Plan
- Annual Performance Bonus
Company overview
PCI Pharma Services is a global contract development and manufacturing organization (CDMO) that provides comprehensive pharmaceutical supply chain solutions to pharmaceutical and biopharmaceutical companies worldwide. Founded in 1991 and headquartered in Philadelphia, Pennsylvania, the company has established itself as a trusted partner in the healthcare industry, offering integrated services that span the entire drug development lifecycle. PCI specializes in drug development support, clinical trial supply management, contract drug manufacturing, sterile and non-sterile drug product packaging, and global pharmaceutical logistics. With a global footprint encompassing 30 GMP-compliant facilities across multiple continents, the company serves as a strategic partner that follows the molecule from early development through commercial launch. PCI's expertise enables clients to accelerate time-to-market while ensuring regulatory compliance and quality standards. The company's comprehensive service portfolio includes analytical services, formulation development, commercial manufacturing, packaging, supply chain management, and distribution, making it a one-stop solution for pharmaceutical companies seeking to outsource their development and manufacturing needs.