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Group Leader, Calibration & Maintenance, BioAnalytics

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.

Catalent’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.

Catalent Pharma Solutions in Kansas City, MO (KCM) is hiring a Group Leader, Calibration & Maintenance, BioAnalytics. The Group Leader, BioAnalytics Calibration and Maintenance is primarily responsible for managing and coordinating all required calibration, preventative maintenance (PM) and coordinating all required maintenance work for the KCM BioAnalytics division. This role has leadership requirements for direct reports (setting goals and expectations, reviews, and development opportunities for team members), helping to maintain the computerized maintenance management system (CMMS), managing the service request/work order process, coordinating calibration and PM work with the analytical labs, assisting in calibration tasks, and other tasks as required. This individual will be helping to maintain and remodel existing facilities, coordinate capital projects, enter service requests into our maintenance software and convert them into work orders, as well as other tasks as required.

This is a full-time on-site salaried position: Monday – Friday on day shift.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role:

+ Own the BioAnalytics calibration program by managing and coordinating all PM activities associated with new/existing equipment and lab spaces including supervision of associates performing Preventative Maintenance and Calibration work for the Biologics department. Support development of asset management according to equipment life cycle

+ Maintaining the spare parts, quantity, and re-order parts for Calibration and PM interests. Performs Maintenance Approver role on department TrackWise records and Computer System Validation (CSV) reviews Support deviation investigation and change control work for PM and calibration action items in TrackWise as required. Schedule PM and Calibration efforts for laboratory equipment in conjunction with Biologics division leadership

+ Support and help drive new CMMS implementation: including data migration, determining and establishing events, measurement data templates, workflows, standardizing equipment list and hierarchy, and supporting validation activities. Developing and maintaining site SOPs for the CMMS and training personnel on the proper use of CMMS. CMMS Administrative support for new/modified/retired equipment, equipment calibrations, and work order management (emergencies & PM)

+ Functioning as the CMMS subject matter expert for the site including extracting data from the CMMS as needed, aligning with Global Engineering best practices for CMMS, and maintain the site’s CMMS users (active/new/modified/deactivated). Liaison with CMMS vendor (Blue Mountain or other) as well as site departments (Engineering, Operations, Validation, and Quality) on technical and support issues

+ Conduct communication with vendors and schedule visits as required by coordinating with SME as well as effectively managing vendors/contractors when they are on-site. Maintain the history and schedule of calibration of equipment and standards. Manage the shipping and receiving of standards, testing units, equipment, and other hardware that may require maintenance or re-calibration

+ Will work independently and with mentoring in compliance with GMPs, Site policies, work instructions, and SOPs to effectively interact with analysts, vendors, site stakeholders, and peers. Define, describe, evaluate, and effectively communicate equipment requirements to both technical experts and non-technical audiences. Will be expected to further knowledge about analytical laboratory systems to support installation and continued preventative maintenance. Drives completion of Continuous Improvement opportunities

+ Manages and coordinates all Maintenance activities associated with new/existing equipment and lab spaces including supervision of associates performing maintenance and engineering work for the BioAnalytical division. Define, describe, evaluate, and effectively communicate facility & equipment requirements to both technical experts and non-technical audiences. Will learn to effectively manage contractors. Ensures adherence to safe work practices and guidelines

+ Will work independently and with mentoring in compliance with GMPs, Site policies, work instructions, and SOPs to effectively interact with customers, design engineers, site stakeholders, and peers. Serves as department subject matter expert for all maintenance and engineering related items during internal client, external client, corporate, and regulatory agency audits

+ All other duties as assigned

The Candidate:

+ Requires a Bachelor’s Degree minimum in a Scientific field; Master’s Degree preferred

+ Must have at least five (5) years of relevant experience within laboratory or pharmaceutical industry with experience supporting Calibration and Preventative Maintenance

+ Supervisory experience is preferred

+ Experience with Computerized Maintenance Management System (CMMS) preferred

+ Requires strong mechanical aptitude for troubleshooting processes/equipment, knowledge of cGMP principles

+ Must have strong computer skills and the ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form

+ **Physical requirements:** On an average 8-hour day this position requires the ability to walk, sit and stand, use hands to handle or feel, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, smell and lift up to 45 pounds. Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently

Why you should join Catalent:

+ Defined career path and annual performance review and feedback process

+ Diverse, inclusive culture

+ Positive working environment focusing on continually improving processes to remain innovative

+ Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives

+ 152 Hours + 8 paid holidays

+ Several Employee Resource Groups focusing on D&I

+ Dynamic, fast-paced work environment

+ Community engagement and green initiatives

+ Generous 401K match

+ Company match on donations to organizations

+ Medical, dental and vision benefits effective day one of employment

+ Tuition Reimbursement – Let us help you finish your degree or start a new degree!

+ WellHub program to promote overall physical wellness

+ Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

**Catalent offers rewarding opportunities to further your career!** Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) to explore career opportunities.

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, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .