Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.
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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.
The Microbiologist I 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.
Essential Duties and Responsibilities: To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.
• 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
Work Environment: The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• 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.
• 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 25 pounds.
• 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.
Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• High School Diploma required. BS/BA degree in Microbiology or related scientific field preferred.
• 3-5 years’ experience in a cGMP environment. Two years of experience may be replaced by Associates/Non- Scientific Bachelor’s degree. Four years of experience may be replaced with BS/BA degree in Microbiology or related scientific field.
• 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
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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.
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What We Do
PCI is a leading provider of integrated pharmaceutical development services to the global healthcare market. With facilities in North America and Europe, PCI supports pharmaceutical and biotech companies with products destined for more than 100 countries around the world. PCI provides services for each stage of the product lifecycle – from early Phase I through commercial launch and long-term supply – and partners with customers to provide key insight and expertise in enabling successful commercialization and bringing lifesaving medications to patients. For more information, go to www.pci.com.
