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CAREERS

BECOME OUR NEXT ENVIRONMENTAL EXPERT!

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Let’s reshape the future of controlled environments together. Opportunities currently exist for certification technicians, supervisors, microbiologists, QA personnel, and HVAC engineers.

current position openings at CEC

To apply for any of our current open positions, please complete the form below.

Controlled Environment Consulting, LLC is looking for a Quality Manager to join its world class team of controlled environment certification, design, and commissioning experts.  This individual should be a dynamic, high-energy professional who is looking for building a rewarding future in developing best-in-class quality systems and processes.

Location: This position will be based in Allentown, PA

Role and Responsibilities:

  • Work HANDS-ON with the operations team, Training Coordinator and Project Engineers to develop and implement a Quality Management System QMS, Internal Auditing and CAPA process for our field services teams   
  • Develop, establish, and monitor Key Performance Indicators (KPIs) and reporting based on the needs of business to support strategy and overall improvements 
  • Conduct investigations to identify root cause of problems and implement effective corrective actions using structured processes
  • Assist and lead internal audit program of the QMS and issue CAPA reports to improve and monitor the health of the QMS
  • Review and approval of change controls, temporary change controls, Investigations and GMP documents (SOPs, work instructions, specifications, etc.)
  • Ensure sustainment of implemented improvements through monitoring data trends
  • Use a data-driven approach to achieve early problem identification and effective resolution
  • Develop and conduct vendor auditing processes
  • Participate in internal, regulatory and customer audits and customer visits at the discretion of management
  • Provide regular reports and actively participate in service team
  • Review, update, and manage internal test equipment calibration and maintenance programs
  • Create and deliver relevant ongoing communications and metric scorecards to respective management, program teams and business teams
  • Develop and oversee manual test report template control process

Skills and Experience:

  • Bachelor’s degree in Science (BS/BA) from a four-year college or university, or five (5) years-related experience and/or training, or equivalent combination of education and experience
  • Knowledge of FDA regulations including cGMP’s and current industry practice required
  • Thorough knowledge of quality control/assurance and/or operations required
  • Experience with quality oversight of GMP computer systems and data is preferred (building automation systems, serialization systems)
  • Above average written and oral communication skills required
  • Above average organizational and planning skills required
  • ASQ CQE, CQMOE and/or CQA (Certified Quality Engineer/Auditor) certification is a definite plus

Summary/Objective

Industry leader in sterile facility design, evaluation, and compliance assurance is seeking a mechanically inclined individual to join our cleanroom performance evaluation team.  This position will expand a team of professionals experienced in sterile facility certification.  The successful candidate will enroll in a world-class cleanroom/ biosafety equipment certification training program conducted by recognized industry leaders.  Generous compensation while in training.  Targeted pay increases as benchmarks are achieved.   Health Benefits, PTO, paid vacations. 

Main Responsibilities

The specific responsibilities of this position include but are not limited to:

  • Perform testing and certification of controlled environments including cleanrooms, biological safety cabinets, laminar flow benches, and other controlled environments
  • Perform microbiological sampling of controlled environments
  • Complete certification reports
  • Troubleshoot and repair or make recommendations for repair of controlled environments including HVAC systems, biological safety cabinets, and other laminar flow systems

 Basic Qualifications/ Core competencies

  • HVAC installation, repair, troubleshooting experience helpful but not required
  • Proficient with Microsoft Office Suite
  • Must be mechanically inclined and able to understand mechanical systems
  • High School Diploma/ GED
  • Technical troubleshooting skills along with strong organizational and problem-solving skills
  • Ability to work flexible hours, including some weekends, and travel as required
  • Good driving record and valid Driver’s license

 Physical Requirements and Working Conditions

  • Travel locally and nationally/ occasional overnight travel required
  • Regular field work
  • Visit construction sites including visual inspections of roof HVAC and exhaust systems
  • Visit customer sites to perform routine testing and other services

Job Type: Full-time

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