QC Microbiologist II

PCI Pharma ServicesLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.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.Summary of Objective: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 roomsMonitor classified clean rooms during manufacturing operations, must gown qualifySample 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 supervisionWrite and execute protocols/experiments/SOPs under limited supervisionReviews work of peers and SOP document changes under limited supervisionMay assist senior staff in preparation of investigations, reports and execution of complex protocolsVisual inspection of media fill vials and platesPerform general lab maintenance/housekeepingTraining of staff in routine processesOther duties as assignedSpecial Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. The employee must be physically capable to perform the duties listed below with or without reasonable accommodations which 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 hearAbility to sit or stand for prolonged periods of timeMust be able to walk and drive between locationsPhysically able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, and protective glovesMust be able to occasionally lift and/or move up to 50 poundsMust pass eye examComfortable with working/handling of hazardous materialsFollow 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 prioritiesWork 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.Communications & Contacts:Interacts with staff across QC, Operations, Facilities, and Validation to coordinate activitiesManagerial & Supervisory Responsibilities:NoneTravel:None. Travel only consists of routine daily movement between buildings.Qualifications:High School Diploma required. BS/BA degree in Microbiology or related scientific field preferred.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.Detail orientedAbility to multi-taskAbility to gown to work in an ISO-5 environmentAbility to work varied hours as required by the production scheduleJoin us and be part of building the bridge between life changing therapies and patients.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.