Certification Manager

VALOGIC BIO LLC•Houston, TX

2d•$70,000 - $90,000•Onsite

About The Position

VaLogic Bio provides crucial technology and compliance services to clients in the life sciences and biotechnology industries; helping organizations establish and remain FDA compliant. Our client services allow scientists to focus their time on the advancement of their life-enhancing therapeutics. This is done through a suite of services that include advisory and facility design, equipment calibration and validation, commissioning, preventative maintenance, laboratory and cleanroom environmental monitoring, and SaaS technology for compliance and continuous monitoring. Our Vision To become the nation’s premier single-source Biopharma solution provider. Mission To support those on the quest for a cure. Job Title: Certification Manager Position Summary Certification Manager is to supervise and perform certification of biological safety cabinet (BSC), Fume Hood and ISO classified cleanrooms

Requirements

Be educated in contamination control principles and how to work within a clean environment or with clean air devices.
Have understanding of cleanroom operation and gowning practices
Be able to evaluate the validity and acceptability of test data and the results reported.
Work requires technical aptitude in order to understand theory and working knowledge of test instruments.
8-12 years of related experience in the HVAC, Cleanroom HEPA Certification, or Life Sciences Services Industry or related field
Strong interpersonal and communication skills, ability to move between task types and remain efficient, show initiative, good planning and organizational skills
Current Valid US driver’s license

Nice To Haves

NSF/CETA or NEBB certified within the past 3 years preferred

Responsibilities

Perform on-site certification of manufacturing cleanrooms including HEPA integrity testing and airborne particulate testing, in accordance with ISO 14644 and other applicable standards.
Perform on-site certification of biological safety cabinets (BSC) and Clean air devices in accordance with NSF and IEST.
Perform on-site certification of fume hoods in accordance with applicable standards.
Perform adjustments and repairs to cleanroom and hoods.
Understand and implement procedures (with client approval) for correcting deficiencies in the performance of cleanroom and hoods.
Adherence to established procedures set forth by VaLogic and/or Clients SOPs and protocols.
Work in a cleanroom utilizing best cleanroom operation guidance and standards.
Generate clear and accurate documentation of test results.
Support the calibration department on special projects.
Support VaLogic validation Services using your knowledge of HVAC components and control systems.
Responsible for developing and facilitating training program of entry level technicians (trainee).
Build client relationships by offering help beyond your daily task list, leveraging our company's knowledge base to support our clients' calibration and maintenance programs.