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 cross-functional 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:**

• Bachelor’s degree in microbiology, chemistry, biology, or related field with 3-5 years of relevant experience (or Master’s degree in the same with 1-2 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)
• Pro-active nature, well organized, and detail oriented with the ability to prioritize tasks with minimal supervision

Additional Information

Position is full-time, Monday-Friday, 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.