Job Overview
Employment Type
Full-time
Compensation
Hourly
Range $27.09 - $31.60
Work Schedule
Day Shifts
Fixed Shifts
Benefits
Paid Time Off
Health Insurance
Dental Insurance
Vision Insurance
Flexible spending account
401(k) Plan
Annual performance bonus
Job Description
PCI Pharma Services is a premier global pharmaceutical contract development and manufacturing organization committed to delivering life-changing therapies to patients worldwide. Renowned for its extensive expertise in aseptic injectable manufacturing, PCI collaborates closely with thousands of biopharma companies, acting as a vital bridge to bring innovative biopharmaceutical products from concept to reality. With a presence in key locations such as Roselle and Lusk, PCI prides itself on its people-first investment strategy, placing emphasis on fostering talented teams that pioneer groundbreaking advancements and shape the future of the pharmaceutical manufacturing landscape.
The company’s culture embodies a commitment to equity, inclusion, and the highest standards of compliance and quality. PCI embraces diversity and strives to create an environment where all employees feel valued and supported in their professional growth. Their global network enables continuous evolution and implementation of cutting-edge technologies, ultimately aiming to enhance patient outcomes by manufacturing superior-quality injectable pharmaceuticals.
The role of Drug Product Manufacturing Associate II is a pivotal position within PCI, responsible for the GMP-compliant production of injectable pharmaceuticals. Positioned primarily in either Roselle or Lusk, this role demands meticulous attention to detail and strict adherence to established Standard Operating Procedures (SOPs) to maintain FDA compliance. The Associate II collaborates with cross-functional teams to prepare and operate manufacturing equipment such as glasswashers, autoclaves, depyrogenation ovens, and automated filling machines, ensuring that each batch meets rigorous quality standards.
Essentially, the Manufacturing Associate II is deeply engaged in aseptic production environments, requiring proficiency in gowning protocols and aseptic techniques fundamental to maintaining sterile conditions. The role extends beyond routine manufacturing tasks to include troubleshooting mechanical and process-related issues, supporting continual improvement initiatives, and documenting batch activities with accuracy. The Associate II works under management supervision to resolve semi-complex operational challenges and assists in research efforts to adopt new methodologies and technologies to optimize production.
The position operates on a 2nd shift schedule starting at 2:00 pm, offering a competitive compensation range of $27.09 to $31.60 per hour along with eligibility for an annual performance bonus. PCI provides full-time employees with an attractive benefits package featuring paid time off, comprehensive health coverage including dental and vision, flexible spending accounts, and a 401(k) retirement plan. The company values reliability, professionalism, and a strong cultural alignment with its mission, requiring associates to exhibit consistent, positive behavior with colleagues and business partners alike.
Joining PCI as a Drug Product Manufacturing Associate II means becoming part of a team dedicated to advancing life-changing therapies while operating in a highly regulated, quality-driven environment. It is an opportunity to develop specialized skills in aseptic manufacturing within a supportive and forward-thinking organization committed to employee development and impactful biopharma solutions.
The company’s culture embodies a commitment to equity, inclusion, and the highest standards of compliance and quality. PCI embraces diversity and strives to create an environment where all employees feel valued and supported in their professional growth. Their global network enables continuous evolution and implementation of cutting-edge technologies, ultimately aiming to enhance patient outcomes by manufacturing superior-quality injectable pharmaceuticals.
The role of Drug Product Manufacturing Associate II is a pivotal position within PCI, responsible for the GMP-compliant production of injectable pharmaceuticals. Positioned primarily in either Roselle or Lusk, this role demands meticulous attention to detail and strict adherence to established Standard Operating Procedures (SOPs) to maintain FDA compliance. The Associate II collaborates with cross-functional teams to prepare and operate manufacturing equipment such as glasswashers, autoclaves, depyrogenation ovens, and automated filling machines, ensuring that each batch meets rigorous quality standards.
Essentially, the Manufacturing Associate II is deeply engaged in aseptic production environments, requiring proficiency in gowning protocols and aseptic techniques fundamental to maintaining sterile conditions. The role extends beyond routine manufacturing tasks to include troubleshooting mechanical and process-related issues, supporting continual improvement initiatives, and documenting batch activities with accuracy. The Associate II works under management supervision to resolve semi-complex operational challenges and assists in research efforts to adopt new methodologies and technologies to optimize production.
The position operates on a 2nd shift schedule starting at 2:00 pm, offering a competitive compensation range of $27.09 to $31.60 per hour along with eligibility for an annual performance bonus. PCI provides full-time employees with an attractive benefits package featuring paid time off, comprehensive health coverage including dental and vision, flexible spending accounts, and a 401(k) retirement plan. The company values reliability, professionalism, and a strong cultural alignment with its mission, requiring associates to exhibit consistent, positive behavior with colleagues and business partners alike.
Joining PCI as a Drug Product Manufacturing Associate II means becoming part of a team dedicated to advancing life-changing therapies while operating in a highly regulated, quality-driven environment. It is an opportunity to develop specialized skills in aseptic manufacturing within a supportive and forward-thinking organization committed to employee development and impactful biopharma solutions.
Job Requirements
- High school diploma required
- Minimum of two 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
Job Qualifications
- High school diploma required
- Bachelor's in a science or engineering discipline preferred
- Minimum of two 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
Job Duties
- 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
- Maintains regular and reliable attendance on a full time basis
- Exhibits professional behavior consistent with company policies and practices
- Embodies PCI Pharma Service’s cultural values and aligns daily actions with department goals and company culture
Job Criteria
Experience
Mid Level (3-7 years)
Job Location
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