Sr. Manager, Maintenance & Engineering

Sr. Manager, Maintenance & Engineering

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.

St. Petersburg is our primary softgel development and manufacturing facility in North America with a capacity of 18 billion capsules per year.  The featured RP Scherer softgel technology is a proven oral drug delivery solution to enhance bioavailability of poorly soluble Rx and OTC drug candidates.  Non-gelatin based OptiShell® and Vegicaps® capsules expand the range of molecules into softgel, ideal for challenging fill formulation. Within the Catalent network, we offer a broad range of integrated formulation.

The Sr. Manager, Maintenance & Engineering will manage the manufacturing engineering team and is responsible for ensuring process equipment is properly maintained and reliable. The Sr. Manager, Maintenance & Engineering will oversee day- to-day operation of equipment as it relates to break-fix, Preventative Maintenance (PM) and Calibration as well as new equipment designs or improvements/upgrades. The Sr. Manager, Maintenance & Engineering will perform metric tracking and lead the equipment reliability program. They can be assigned by the SLT to lead special “Hit Team” projects that target’s efficiency improvements to critical asset. This requires leading cross function team members to accomplish the goal (Process or Equipment). This role would be expected to present status updates to SLT and executive leaders.

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

• Manages the repair and maintenance budget, ensuring compliance with Health, Safety, and Environmental requirements.

• Works cross-functionally with other engineering departments, operations, finance, continuous improvement, and quality to drive process and equipment improvements.

• Improves and generates equipment reliability metrics to drive and prioritize process improvement projects, while managing site PM and Calibration and equipment reliability programs.

• Ensures Quality compliance for direct reports for Training, CAPA, Incident investigations, internal and regulatory audits, and maintains the corrective work order program.

• Maintains equipment Spare Part inventory program and relationships with key equipment and process vendors to stay up to date with technological and equipment advances.

• Mentors and leads direct reports in root cause analysis and PR closure, maintaining focus and priority for manufacturing engineers to reduce overdue deviations.

• Interviews candidates, evaluates and counsels’ staff as appropriate, in conjunction with Human Resources, and ensures that direct reports are appropriately trained in cGMP’s, Company policies, and procedures related to their responsibilities, including process-specific training at OEM partners.

• Perform other duties as assigned.

The Candidate

• BS in an Engineering or a Science related field is required.

• 3+ years of management experience is required.

• Experience working within a regulated environment is required.

• Ability to communicate effectively with engineers, technicians, customers, staff, and other personnel

• Ability to provide detailed documentation in support of projects; includes business case analysis based on historical data or industry standards, Strong organizational skills.

• Ability to troubleshoot simple to complex process and equipment problems.

• Ability to plan, coordinate, and control work under aggressive timelines  

• Must be able to work with a high degree of autonomy, multi-task and demonstrate diplomatic skills. 

• Individuals may be required to sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequentl