Associate Manager, Site Assets and Calibration

Biomérieux - St. Louis, MO3.8

Full-time
A strong Scientific and technological pioneering spirit drives bioMérieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioMérieux commitment to public health.
bioMérieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products.
We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.

A strong Scientific and technological pioneering spirit drives bioMérieux development since its creation in 1963. We design innovative in vitro diagnostic solutions for our customers that initiate new forms of scientific partnerships to be at the forefront of the most advanced technologies. Our presence in more than 150 countries with 9,400 employees worldwide secures bioMérieux commitment to public health.

bioMérieux products are used to diagnose infectious diseases, they provide high medical value results for cancer screening and monitoring, cardiovascular emergencies and contamination to improve patient health and ensure consumer safety. Products also include industrial microbiological controls to detect microorganisms in food, pharmaceutical and cosmetic products.

We are committed to creating an optimal work environment that fosters teamwork, emphasizes training and offers international career development opportunities.

PRIMARY PURPOSE AND OVERALL OBJECTIVE OF THE JOB:
Responsible for the management of the site assets and equipment calibration to ensure the control of inspection, measuring, and test equipment, or other relevant critical assets in a regulated medical device manufacturing environment.

MAIN ACCOUNTABILITIES
  • Oversee the asset and calibration program to ensure all aspects of the program are properly implemented, managed, and tracked throughout the site.
  • Coordinate internal calibration scheduling with external calibration service providers.
  • Utilize regulatory asset management system to maximize efficiency and quality.
  • Manage a staff of technicians responsible for calibration and asset coordination with site functional groups.
  • Work cross-functionally with Manufacturing, Engineering, Line Maintenance, R&D, Quality, Finance and other relevant functional groups to ensure participation and accountability from a quality and compliance perspective.
  • Deliver consistent and compliant out-of-tolerance investigations in accordance with regulatory requirements and Quality System policies and procedures.
  • Provide timely and accurate asset and calibration program documentation as necessary to support inspections by the FDA, regulatory agencies, or certifying bodies.
  • Monitor asset and calibration program against established metrics and timelines.
  • Ensure that all health, safety, and environmental requirements are fulfilled.
KNOWLEDGE AND EXPERIENCE REQUIRED FOR THE JOB:
  • Bachelor Degree in Engineering, Electronics Engineering Technology, or Life Sciences is highly preferred with 5+ years related experience. Equivalent combination of relevant experience and education will be considered in lieu of the degree.
  • Detailed knowledge of calibration requirements and guidance established by ISO 17025, NIST, ASTM or other related agencies.
  • Detailed knowledge of asset management, calibration technology and techniques, and metrology to ensure appropriate use of inspection, measuring, and test equipment.
  • 5+ years of experience using CMMS systems. Experience with Blue Mountain preferred but not required.
  • Demonstrated ability to collaborate professionally with all levels of management in a cross-functional team environment.
  • Experience in FDA regulated environment with general understanding of equipment and process validation requirements is preferred.
  • Proficiency in the use of Microsoft Office (Word, Excel, PowerPoint, and Outlook) is required.
  • Demonstrated effective communication and interpersonal skills.
  • Proficient in problem-solving skills using analytical methods.
  • Ability to lead cross functional teams and provide technical expertise.
  • Ability to answer support calls as needed to support a 24-7 manufacturing operation.
  • Ability to work as a team player and cohesive group member
  • This job may require domestic travel and the possibility of international travel. The amount of travel could be up to 5% at times as directed by department management.
bioMérieux is an Equal Opportunity, Affirmative Action Employer. M/F/Vet/Disability/Sexual Orientation/Gender Identity