Environmental Monitoring Specialist

at MilliporeSigma
Location 645 Science Drive, Madison, Wisconsin
Date Posted May 25, 2021
Category Bioscience
Job Type Full-time
Address 645 Science Drive

Description

Your Role: 

MilliporeSigma in Madison, Wisconsin is searching for an Environmental Monitoring Specialist.  Environmental Monitoring (EM) is a critical component of GMP manufacturing. The EM team consistently monitors the air, compressed gas systems and water systems within manufacturing facilities to meet required specifications. The EM specialist will lead daily compliance, deviations and nonconformance closure and process improvement efforts.

Responsibilities:

  • Maintaining compliance in EM, compressed gasses, and purified water sampling
  • Training analysts
  • Identifying program and documentation gaps, defining solutions
  • Managing and completing process and program improvements
  • Completing EM and facility-related investigations (NCRs, CAPAs and change controls)
  • Assist in leading and developing a team of qualified professionals to manage all quality control aspects of the environmental monitoring program to ensure that process and procedures are in compliance with cGMP for API manufacture in a contract manufacture organization
  • Collaborating with customers to determine the appropriate environmental monitoring strategy for the site and customer specific projects
  • Selection of analytical and sampling methods appropriate to the processes and site to meet appropriate environmental controls
  • Compilation, development and execution of associated trend reports and qualification documentation in line with cGMP standards
  • Assist with providing leadership and organizing departmental staff to meet deadlines without compromising quality

 

Who you are: 

Minimum Qualifications 

  • Bachelor’s degree in Biology, Microbiology or other Scientific discipline with 3+ years’ environmental monitoring experience in pharma or related industry

 

Preferred Qualifications 

  • EM and water sampling experience
  • EM regulatory compliance knowledge
  • Knowledge of EM-specific sampling instrumentation
  • Previous leadership experience
  • Effective oral and written communication skills
  • Effective organizational and time-management skills
  • Understanding of technical information
  • Understanding of instrumentation

 

Click here to learn more & apply today!