19 days old

Environmental Conditions Manager

Andelyn Biosciences
Columbus, Ohio 43205
  • Job Type
    Employee, Contract
  • Job Status
    Full Time
  • Shift
    1st Shift

It’s an exciting time to join us!

 

The Andelyn Biosciences’ Facility & Contamination Control group is seeking a motivated individual to join our growing team as an Environmental Conditions Manager.

 

The Environmental Conditions Manager will complete the principal duties and responsibilities outlined below. Working in collaboration with leadership and senior staff, the Manager will plan and oversee the development, implementation, and execution of critical cleanroom contamination control strategies. Activities may include oversight of routine environmental monitoring (EM) program, approval of EM trending reports, investigation of quality events, development and management of corrective action / preventative action (CAPA), oversight of project timelines/tasks, approval of technical and procedural documents, as well training and mentoring junior staff. The Manager will support efforts to deliver all products in a timely, compliant, and fiscally responsible fashion.

 

Schedule: Full-time (Benefits Eligible)

Location: Central Campus 700 Children's Drive Columbus, OH 43205.

 

Under the guidance and direction of Facility & Contamination Control Leadership, essential functions of the Environmental Conditions Manager include at a minimum: ·

 

  • Anticipating problems and removing obstacles to enable staff to perform tasks as assigned
  • Have significant latitude for making decisions for the operational/functional unit
  • Managing and influencing people indirect or lateral reporting structure
  • Oversee routine EM sampling schedule
  • Developing and enforcing procedures and controls related to environmental monitoring and associated reporting and trending practices – may include, but is not limited to, standard operating procedures, work instructions, technical protocols, technical reports
  • Participate in cross-functional quality event investigations related to EM excursions / adverse trends
  • Analyze data summaries for quarterly EM trending reporting
  • Identifies and initiates an investigation of adverse EM trends
  • Present quarterly EM trending findings to Andelyn Quality Council and Contamination Control Committee.
  • Responsible for hiring, development, and related personnel processes.
  • Has budgetary responsibility.
  • Cultivate a diverse and collaborative team environment.
  • Utilizes clear and concise communication to deliver high productivity and contribution to the success of department goals.
  • Performs in accordance with established policies, procedures, and techniques and requires training common experience or working knowledge related to the tasks performed.
  • Frequent involvement and ultimate responsibility in audits and customer relations.
  • Operate within the Quality Management System applicable to the manufacture of phase-appropriate material in the CMF.
  • Maintain compliance with applicable regulatory requirements for cellular and gene therapy products.
  • Demonstrate a high level of integrity
  • Attention to detail in all job functions
  • Maintain positive attitude
  • Exercise crucial people skills
  • Other duties as assigned

 

Requirements

Knowledge, Skills, and Abilities required

 

  • Requires a relevant four-year degree with at least eight years of relevant experience in pharmaceutical environmental monitoring/microbiology.
  • Proficiency in GMP is required.
  • Has in-depth working knowledge and understanding of microbial environmental monitoring – basic understanding of non-viable particulate monitoring is desired
  • Experience with quality event investigation is required.
  • Experience with microbiology in aseptic manufacturing cleanroom environments preferred.
  • Prior supervisory experience is highly preferred

 

Minimum Physical Requirements

 

  • There are very minimal physical requirements. One needs to be able to lift 20-30 pounds occasionally (0-33% of the time).
  • May require the ability to aseptically gown or wear other PPE on regular basis.
  • Must be able to stand for extended periods.

 

EOE M/F/Disability/Vet

Categories

Posted: 2021-11-18 Expires: 2021-12-18

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Environmental Conditions Manager

Andelyn Biosciences
Columbus, Ohio 43205

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