Environmental Monitoring Specialist Pharmaceutical Clean RoomUtilities
Environmental Monitoring Specialist Pharmaceutical Clean RoomUtilities
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Eurofins Professional Scientific Services is searching for an Environmental Monitoring Specialist to support our client in West Point PA providing environmental monitoring/control of clean rooms in a pharmaceutical manufacturing environment.
EM Specialist responsibilities include but are not limited to the following:
- Provide environmental monitoring support to GMP manufacturing areas.
- Work independently and with crossfunctional groups to implement the environmental monitoring program to ensure the compliance of facilities and utility systems
- Trending and evaluation of environmental data against specifications
- Generation of reports and investigations
- Author/update Master EM Plans
- Author/update RQ protocols final reports
- Perform EM Investigations and Root Cause Analysis
- Review EM Annual Reviews
- Assist Lead EM Specialist with Technician work scheduling
- Assist Lead EM Specialist with LIMS sample and schedule maintenance
- Assist Lead EM Specialist with SOP creation and update
Qualifications :
Basic Minimum Qualifications:
- Bachelors degree in microbiology chemistry biology or related field with 35 years of relevant experience (or Masters degree in the same with 12 years of relevant experience)
- Authorization to work in the United States indefinitely without restriction or sponsorship
The ideal candidate would possess:
- Knowledge of cGMPs
- Prior Environmental Monitoring experience
- Prior Aseptic Processing and/or Aseptic Gowning experience
- Experience with LIMS Trackwise OpenText Documentum D2 (MEDS) Kneat Gx (eVal) Veeva or other Electronic Document Management System SAP QN
- Demonstrated ability to work both independently and as part of a team
- Demonstrated leadership and teamwork skills established written and verbal communication skills (with focus on SOP authoring investigation authoring attention to detail)
- Proactive nature well organized and detail oriented with the ability to prioritize tasks with minimal supervision
Additional Information :
Position is fulltime MondayFriday generally 8 a.m. 5 p.m. with overtime as needed. Candidates currently living within a commutable distance of West Point PA are encouraged to apply.
- Excellent full time benefits including comprehensive medical coverage dental and vision options
- Life and disability insurance
- 401(k) with company match
- Paid vacation and holidays
Eurofins USA PSS Insourcing Solutions is a Disabled and Veteran Equal Employment Opportunity employer.
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
