Catalent
Group Leader, Calibration & Maintenance, BioAnalytics
Catalent, Kansas City, Missouri, United States, 64101
Position Summary:
Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually.
Catalan t’s Kansas City facility is home to our Clinical Delivery Services and Biologics Analytical Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture. The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.
The Role:
Group Leader, BioAnalytics Calibration and Maintenance: responsible for managing and coordinating all required calibration, preventive maintenance (PM) and associated maintenance work for the KCM BioAnalytics division. Includes leadership of direct reports, CMMS maintenance, service requests/work orders, calibration tasks, and related activities. Also assists in facility remodeling, capital projects, and converting service requests into work orders.
Own the BioAnalytics calibration program by supervising PM and calibration activities for new/existing equipment and lab spaces; support asset management according to equipment life cycle; maintain spare parts and re-order levels.
Serve as Maintenance Approver for TrackWise records and participate in CSV reviews; support deviation investigations and change control for PM and calibration items; schedule PM and calibration efforts with Biologics division leadership.
Contribute to CMMS implementation efforts: data migration, event definitions, data templates, workflows, equipment hierarchy, standard operating procedures, and user training. Provide CMMS administrative support (equipment, calibrations, work orders).
Act as CMMS site subject matter expert, align with Global Engineering practices, manage CMMS users, and liaise with CMMS vendors and site departments on technical issues.
Coordinate with vendors and on-site visits, manage calibration history and scheduling of equipment standards, and oversee shipping/receiving of standards and equipment requiring maintenance or re-calibration.
Interact with analysts, vendors, site stakeholders, and peers in GMP-compliant environments; communicate equipment requirements to technical and non-technical audiences; pursue continuous improvement opportunities.
Direct maintenance activities for new/existing equipment and lab spaces; ensure safe work practices; manage contractors; audit support during internal/external audits as department SME.
Other duties as assigned.
The Candidate:
Requires a Bachelor’s Degree (minimum) in a scientific field; Master’s Degree preferred.
At least five (5) years of relevant experience in a laboratory or pharmaceutical setting with calibration and preventive maintenance responsibilities.
supervisory experience is preferred.
Experience with Computerized Maintenance Management System (CMMS) preferred.
Strong mechanical aptitude for troubleshooting processes/equipment; knowledge of cGMP principles.
Strong computer skills; ability to interpret varied instructions (written, oral, diagrams, schedules).
Physical requirements: ability to walk, sit, stand; lift up to 45 pounds; vision requirements for reading and computer use.
Why you should join Catalent:
Defined career path and annual performance review process
Diverse, inclusive culture
Positive working environment focused on process improvement and innovation
Career growth opportunities within a growing organization
Medical, dental and vision benefits effective day one
Tuition reimbursement and wellness programs
Retirement plan with generous match
Employee resource groups; community engagement and green initiatives
Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please contact DisabilityAccommodations@catalent.com with the job number, title and location.
Notice to Agency and Search Firm Representatives: Catalent is not accepting unsolicited resumes from agencies or search firms for this job posting.
Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide sensitive information during the offer process. If you receive such requests, report them to spam@catalent.com.
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The Role:
Group Leader, BioAnalytics Calibration and Maintenance: responsible for managing and coordinating all required calibration, preventive maintenance (PM) and associated maintenance work for the KCM BioAnalytics division. Includes leadership of direct reports, CMMS maintenance, service requests/work orders, calibration tasks, and related activities. Also assists in facility remodeling, capital projects, and converting service requests into work orders.
Own the BioAnalytics calibration program by supervising PM and calibration activities for new/existing equipment and lab spaces; support asset management according to equipment life cycle; maintain spare parts and re-order levels.
Serve as Maintenance Approver for TrackWise records and participate in CSV reviews; support deviation investigations and change control for PM and calibration items; schedule PM and calibration efforts with Biologics division leadership.
Contribute to CMMS implementation efforts: data migration, event definitions, data templates, workflows, equipment hierarchy, standard operating procedures, and user training. Provide CMMS administrative support (equipment, calibrations, work orders).
Act as CMMS site subject matter expert, align with Global Engineering practices, manage CMMS users, and liaise with CMMS vendors and site departments on technical issues.
Coordinate with vendors and on-site visits, manage calibration history and scheduling of equipment standards, and oversee shipping/receiving of standards and equipment requiring maintenance or re-calibration.
Interact with analysts, vendors, site stakeholders, and peers in GMP-compliant environments; communicate equipment requirements to technical and non-technical audiences; pursue continuous improvement opportunities.
Direct maintenance activities for new/existing equipment and lab spaces; ensure safe work practices; manage contractors; audit support during internal/external audits as department SME.
Other duties as assigned.
The Candidate:
Requires a Bachelor’s Degree (minimum) in a scientific field; Master’s Degree preferred.
At least five (5) years of relevant experience in a laboratory or pharmaceutical setting with calibration and preventive maintenance responsibilities.
supervisory experience is preferred.
Experience with Computerized Maintenance Management System (CMMS) preferred.
Strong mechanical aptitude for troubleshooting processes/equipment; knowledge of cGMP principles.
Strong computer skills; ability to interpret varied instructions (written, oral, diagrams, schedules).
Physical requirements: ability to walk, sit, stand; lift up to 45 pounds; vision requirements for reading and computer use.
Why you should join Catalent:
Defined career path and annual performance review process
Diverse, inclusive culture
Positive working environment focused on process improvement and innovation
Career growth opportunities within a growing organization
Medical, dental and vision benefits effective day one
Tuition reimbursement and wellness programs
Retirement plan with generous match
Employee resource groups; community engagement and green initiatives
Catalent is an Equal Opportunity Employer, including disability and veterans. If you require reasonable accommodation for any part of the application or hiring process due to a disability, please contact DisabilityAccommodations@catalent.com with the job number, title and location.
Notice to Agency and Search Firm Representatives: Catalent is not accepting unsolicited resumes from agencies or search firms for this job posting.
Important Security Notice to U.S. Job Seekers: Catalent NEVER asks candidates to provide sensitive information during the offer process. If you receive such requests, report them to spam@catalent.com.
#J-18808-Ljbffr