Pharmaceutical Manufacturing Environmental Monitoring Specialist

Eurofins USA PSS Insourcing Solutions

Pharmaceutical Manufacturing Environmental Monitoring Specialist

West Point, PA
Full Time
Paid
  • Responsibilities

    Job Description

    ** Eurofins Professional Scientific Services is searching for an Environmental Monitoring Specialist to support our client in West Point, PA.**

    ** 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

    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.