Summary

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.

Job description

Essential Duties and Responsibilities

Performs routine Environmental Monitoring of the classified clean rooms.
Performs routine utility sampling and analysis of Water for Injection Systems, RO/DI, USP Purified water systems, and Clean Steam systems.
Monitors classified clean rooms during manufacturing operations; must be gown qualified.
Performs routine monitoring and analysis of the Clean Compressed Air System.
Executes protocols/experiments/SOPs under minimal supervision.
Reviews work of peers and SOP document changes under minimal supervision.
Assists senior staff in preparation of investigations, reports and execution of complex protocols.
Assists in authoring and collaborating on SOP creation and updates.
Conducts visual inspection of media fill vials and plates.
Trains staff in routine processes.
Performs general lab maintenance/housekeeping.

Special Demands

Required to stand; walk; sit; use hands to finger, handle or feel objects, tools or controls; reach with hands and arms; balance; talk and hear.
Ability to sit or stand for prolonged periods of time.
Must be able to walk and drive between locations.
Physically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective gloves.
Must be able to occasionally lift and/or move up to 50 pounds.
Must pass eye exam.
Comfortable with working/handling of hazardous materials.
Follow written instructions.
Perform independent troubleshooting of common issues.
Able to work in a highly complex environment with competing demands and priorities.

Qualifications

High school Diploma, GED, or equivalent credential required; AS degree or BS degree in Microbiology or related scientific field preferred.
5-7 years' experience in a cGMP environment; equivalent combination of education and experience will be considered.
Highly detail-oriented.
Easily adaptable to changing priorities and deadlines.
Exceptional organizational skills.
Professional verbal communication skills required.
Excellent computer skills; the ability to learn new software.
Ability to work varied hours as required by the production schedule.
Working/theoretical knowledge of lab equipment.
Ability to identify and execute process improvements.
Ability to gown to work in an ISO-8 through ISO-5 environment.

Requirements

High school Diploma, GED, or equivalent credential required
AS degree or BS degree in Microbiology or related scientific field preferred
5-7 years' experience in a cGMP environment
Highly detail-oriented
Easily adaptable to changing priorities and deadlines
Exceptional organizational skills
Professional verbal communication skills required
Excellent computer skills; ability to learn new software
Ability to work varied hours as required by production schedule
Working/theoretical knowledge of lab equipment
Ability to identify and execute process improvements
Ability to gown to work in an ISO-8 through ISO-5 environment
Must pass eye exam
Comfortable working with/handling hazardous materials
Must be able to occasionally lift and/or move up to 50 pounds

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.