Process Engineer; Reliability

Process Engineer (Reliability)

St. Petersburg in the primary softgel development and manufacturing facility in North America. The site has the capability to develop lipid formulations in a dedicated pilot plant which supports rapid transition from laboratory scale to clinical supply. Liquid in bottle, as well as Liquid fill Hard shell capabilities at the facility provide diversification and offerings that increase the speed to clinic.

Within the Catalent network, we offer a broad range of integrated formulation and analytical services to solve your most difficult development and manufacturing challenges. Our analytical laboratory provides a full service offering from development of analytical methods to routine QC testing, supporting commercial and development stability studies. With capacity to generate over 18 billion softgels per year and servicing over 100 markets globally, the St.

Petersburg site can handle any Over the Counter (OTC), Prescription (Rx), Medical Device, Controlled Substance, or Dietary Supplement manufacturing needs. The facility also contains a segregated hormone manufacturing area that meets current regulatory requirements. In addition to the manufacturing of traditional animal based gelatin softgels, St. Petersburg site manufactures products in non-gelatin based Opti Shell® and Vegicaps® to expand the range of molecules that can be encapsulated.

We have an opportunity for a Process Engineer (Reliability) to join our team in St. Petersburg, Florida. In this role, you will manage site reliability assets across operations, technical services, and process development. You will work on projects that impact technical services for new or enhanced products, engineering, cost containment, and compliance initiatives. This position requires strong cross-functional communication and collaboration with customers, vendors, suppliers, contractors, and senior management.

Shift:

Work Schedule:

Monday
-Friday, 8:00 AM-4:30 PM or 8:30 AM-5:00 PM with a 30-minute unpaid lunch

Location:

St. Petersburg, FL 100% Onsite

• Develop engineering solutions to repetitive failures such as capacity, quality, cost, or regulatory compliance issues using tools like Statistical Process Control, Reliability Modeling and Prediction, Six Sigma methodology, and Root Cause Analysis.
• Provide advanced engineering support to ongoing activities and projects, acting as a specialist advisor across the Reliability Engineering function and applying value analysis to repair or redesign decisions.
• Accountable for Preliminary Hazards Analysis, Failure Modes and Effects Analysis, Criticality Analysis, and Root Cause Analysis.
• Develop and maintain Life Cycle Asset Management and participate in design and installation specifications along with commissioning plans.
• Participate in evaluation of equipment, technical maintenance service providers, and final check-out of new installations including factory and site acceptance testing.
• Lead cross-discipline projects focused on Reliability Engineering and develop plans to eliminate or reduce losses through root cause analysis, facilitating implementation. May work off hours for projects or plant emergencies.
• Communicate with customers on equipment status and with suppliers, vendors, or contractors on equipment requirements and expectations. Ensure project requirements meet current cGMP, EHS, and CFR/ISO industry standards.
• Perform other duties as assigned.

Minimum Requirements

• Bachelor's degree in science or engineering
• Ability to work effectively under pressure to meet deadlines. May be required to sit, stand, walk regularly and occasionally lift up to 20 pounds, no lifting greater than 44 pounds without assistance.
• Be accessible to manufacturing floor and office staff and use required office equipment. Specific vision requirements include reading written documents and frequent use of a computer monitor.

Preferred Skills & Background

• Excellent communication skills
• Ability to develop solutions to moderately complex problems
• Knowledge and experience in using and designing business systems to document and solve problems
• Knowledge of CMMS
• Previous experience with…