Cleanroom Supervisor

2 weeks ago

Oklahoma City, Oklahoma, United States Fagron GmbH & CO. KG Full time
About the Role

We are seeking a highly skilled Cleanroom Supervisor to join our team at Fagron GmbH & CO. KG. As a Cleanroom Supervisor, you will play a critical role in ensuring the smooth operation of our ISO 5 VLFH within an ISO 7 environment.

Key Responsibilities
  • Successfully pass and remain gowning qualified for entrance into the ISO 7 cleanrooms.
  • Successfully pass media fill and remain qualified to assist with tasks within the ISO 5 VLFH as required.
  • Assist in overseeing all ISO 7 cleanroom activities, including cleaning of VLFHs, preparation of materials, manual aseptic filling of drug product, and performing calibration checks.
  • Ensure compliance to SOPs, batch records, and HR policies, and assist in disciplinary action as needed.
  • Meet Right First Time (RFT) metrics by reducing error/deviations and completing corrections quickly.
  • Review and maintain adherence to the manufacturing schedules.
  • Track employee training to ensure compliance.
  • Aid in bi-annual reviews of procedures.
  • Provide on-the-floor leadership to the production team.
  • Assist in coaching and training of technicians in the manufacturing suites.
  • Support process improvements and scale up initiative within the department.
  • Approve electronic time keeping for reports.
  • Manage personnel to operational standards and complete performance evaluations.
Requirements
  • Minimum of 3 years of experience working in a regulated/GMP environment with a minimum of 1 year experience in a leadership position.
  • Minimum of 1 year ISO 7 cleanroom experience, ISO 5 experience a plus.
  • Good working knowledge of appropriate cleanroom behavior and aseptic technique.
  • Solid math and effective problem-solving skills with demonstrated use of sound judgement.
  • Good communication, verbal and electronic, and organizational skills, strong interpersonal skills.
  • Demonstrated ability to work effectively and lead a team.
What We Offer

We believe in our people and foster a supportive environment that develops and rewards performance and incentivizes long-term career success. Our benefits include, but are not limited to:

  • Competitive Salary
  • Health, Vision, and Dental Insurance
  • Company Paid Life Insurance
  • Generous Paid Holidays
  • Paid Volunteer Time
  • Generous Paid Time Off and Rollover
  • Company matching 401K and Retirement Savings Plans
  • Employee Assistance Program
  • Flexible working arrangements

We are an equal opportunity employer and welcome applications from diverse candidates. If you are passionate about personalized medicine and want to be part of a dynamic organization, please submit your application.

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