Environmental Monitoring Supervisor

4 weeks ago

Tampa, Florida, United States Bausch + Lomb Full time

Job Title: Environmental Monitoring Supervisor

Job Summary:

Bausch + Lomb is seeking an experienced Environmental Monitoring Supervisor to oversee the Environmental Monitoring (EM) program for our facility in accordance with regulatory requirements. The successful candidate will supervise EM personnel performing routine and non-routine environmental monitoring in support of sterile manufacturing operations.

Key Responsibilities:

  • Management and scheduling of day-to-day EM activities/personnel to meet Manufacturing needs.
  • Coordinate with Manufacturing and other departments to solve/prevent production related problems.
  • Ensure EM personnel are properly trained/qualified to perform assigned tasks.
  • Provide coaching and conduct performance evaluations for EM personnel to support career development.
  • Ensure site and department objectives are communicated and met.
  • Draft and/or approve validation protocols/reports (ex. EMPQs).
  • Draft and/or approve EM procedures for enhancement, clarity, corrections, etc.
  • Oversee inventory of EM equipment and supplies.
  • Oversee non-routine monitoring in conjunction with investigations, projects, and/or validation activities.
  • Oversee visual inspection of media fill units for turbidity/microbial contamination.
  • Ensure EM excursions are properly investigated and effective CAPAs are implemented to prevent recurrence.
  • Coordinate microbiology data release activities including compilation, review, data entry, etc.
  • Oversee the trending of EM data.
  • Oversee the collection of critical utility samples (WFI/Pure Air).
  • Represent the EM function during audits.
  • Implement continuous improvement initiatives within the department to reduce costs, increase compliance, reduce timelines, increase efficiencies, etc.

Requirements:

  • Bachelor's degree in Microbiology, Biology, or equivalent Life Science required.
  • 5+ years of relevant work experience required, preferably in Microbiology and/or Environmental Monitoring in an Aseptic Manufacturing Facility.
  • 2+ years of leadership experience preferred.

Physical Requirements / Working Conditions:

  • Ability to lift and/or carry 25 lbs.
  • Ability to achieve 20/20 correctable vision.
  • Ability to maintain proper personal hygiene.
  • Ability to wear laboratory PPE/attire.
  • Ability to gown aseptically and work in a controlled environment for extended periods of time (no makeup, jewelry, fingernail polish, etc.).

Required Knowledge, Skills, & Abilities:

  • Ability to communicate effectively with direct reports, peers, and management.
  • Ability to work in a fast-paced environment.
  • Ability to work full-time, onsite, including overtime and weekends if necessary to meet department/site objectives.
  • Strong leadership, time management, planning, and organizational skills.
  • Thorough knowledge of Aseptic Manufacturing processes and applicable regulations (e.g. FDA, USP, ISO, etc.).
  • Excellent oral and written communication skills.
  • Advanced knowledge of microbiological testing/environmental monitoring techniques.

Eligibility for Internal Applicants:

  • Must meet the minimum required qualifications for this position.
  • Must have been in current position for NLT 12 months.
  • No written warnings in the past 6 months.
  • No final warnings in the past 12 months.
  • Not currently on a performance improvement plan.

Our Benefit Programs:

Applicants must be authorized to work for ANY employer in the U.S. We are unable to sponsor or take over sponsorship of an employment Visa at this time.

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