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.

JOB SUMMARY

Conducts sampling and testing of production environments, and/or facility clean utilities, as per approved procedures.  Performs Lab work and other tasks as assigned by management.

JOB DUTIES

• Perform routine Environmental Monitoring of the classified clean rooms

• Monitor classified clean rooms during manufacturing operations, must gown qualify

• Sample and test the Water for Injection System, USP Purified Water systems and Clean Steam systems; perform and document plate reads for all environmental and utility testing with minimal supervision

• Write and execute protocols/experiments/SOPs under limited supervision

• Reviews work of peers and SOP document changes under limited supervision

• May assist senior staff in preparation of investigations, reports and execution of complex protocols

• Visual inspection of media fill vials and plates

• Perform general lab maintenance/housekeeping

• Training of staff in routine processes

• Other duties as assigned

PROFESSIONAL SKILLS

• Exceptional organizational skills

• Detail oriented

• Professional verbal communication skills required

• Solid computer skills

• Ability to work varied hours as required by the production schedule

• Working/theoretical knowledge of lab equipment

• Ability to identify process improvements

EXPERIENCE

• 5-7 years’ experience in a cGMP environment.  Two years of experience may be replaced by Associates/Non- Scientific Bachelor’s degree.  Three years of experience may be replaced with BS/BA degree in Microbiology or related scientific field.

EDUCATION

• High School Diploma required. BS/BA degree in Microbiology or related scientific field preferred

QUALITIES

• Detail oriented

• Ability to multi-task

• Ability to gown to work in an ISO-5 environment

• Ability to work varied hours as required by the production schedule

PHYSICAL REQUIREMENTS & MENTAL 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. Provide expertise for response to complex issues.

• Able to work in a highly complex environment with competing demands and priorities

COMMUNICATIONS & CONTACTS

• Interacts with staff across QC, Operations, Facilities, and Validation to coordinate activities

#LI-LL1

Join us and be part of building the bridge between life changing therapies and patients. Let’s talk future

Equal Employment Opportunity (EEO) Statement:
PCI Pharma Services is an Equal Opportunity/Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status.

At PCI, Equity and Inclusion are at the core of our company’s purpose: Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and workplace culture.