Process Engineer (Reliability)

Process Engineer (Reliability)

About Site

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 OptiShell® and Vegicaps® to expand the range of molecules that can be encapsulated.

Position Summary

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

The Role

• 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.

The Candidate

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 predictive maintenance technologies and asset performance platforms

Why You Should Join Catalent

• Positive and fast-paced working environment focusing on continually improving processes to remain innovative and dynamic

• Competitive Paid Time Off plus 8 paid holidays

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

• Tuition Reimbursement – support to finish your degree or earn a new one

• Employee Resource Groups focusing on Diversity and Inclusion

• Environmentally friendly initiatives including regular participation in community beach clean-ups

• Defined career path and annual performance review process with potential for career growth

• WellHub program promoting overall physical and mental wellness

• Perkspot offers exclusive discounts from over 900 merchants in various 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 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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.