Drug Product Manufacturing Associate I - 1st and 2nd Shift Weekend Schedule
PCI Pharma Services
Summary
The Manufacturing Associate I 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
This opening schedule will eventually include supporting weekend operations. Must be able to work a schedule that will include working on Saturday and Sunday. Schedule: TBD.
Essential Duties and Responsibilities
- Train in one or more areas of the aseptic manufacturing injectable pharmaceuticals using GMPs in FDA regulated facility.
- Train on required SOPs and execute training curriculum.
- Prepare materials needed for aseptic operations.
- 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.
- Perform various routine manufacturing tasks on complex equipment under the guidelines of established SOPs and cGMP regulations.
- Accurately document data and complete batch records as needed.
- Reliably execute well defined SOPs.
- Operate in clean room environments in accordance with established policies and procedures.
- Collect and dispose of lab wastes according to established procedures.
- Maintain regular and reliable attendance on a full time basis.
- Embody PCI Pharma Service's cultural values and align daily actions with department goals and company culture.
Qualifications
- High school diploma required. Bachelors in a science or engineering discipline preferred.
- Minimum of zero to two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions.
- Ability to follow instructions with direct supervision.
- Detail oriented with strong written and verbal communication skills.
- 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
- Occasionally required to sit, and to reach to use computers and other office equipment.
- Occasionally stand for extended periods of time, up to four (4) hours/time.
- Occasionally required to lift up to 40 pounds.
- Constantly required to view objects at close and distant ranges.
- Frequently required to communicate with others.
Requirements
- High school diploma required
- Bachelors in a science or engineering discipline preferred
- Minimum of zero to two (2) years of relevant experience in manufacturing, laboratory, mechanical or engineering positions
- Ability to follow instructions with direct supervision
- Detail oriented with strong written and verbal communication skills
- 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
- Must be able to work a schedule that includes Saturday and Sunday
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.