Project Engineer

3 weeks ago

Winchester, Kentucky, United States Catalent Inc Full time
Project Engineer

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 is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent employee. Catalent's Winchester location is the flagship US manufacturing location for large scale oral dose forms, with integrated analytical and development services. With 28 years of expertise in product development, technology transfers and commercial manufacturing, and roots in industry-leading Glatt technology.

The Project Engineer is a member of the Capital Projects Team within the Continuous Improvement, Technology, and Engineering Department. The Project Engineer drives the site and facility improvement agenda and supports the Site Capital Plan.

Monday-Friday 8 AM-5 PM

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
  • Ensures compliance to scope, cost and schedule.
  • Drive continuity and development of standards in Project Engineering to ensure smooth and effective communication flow between internal resources and customers, operational efficiency, and equipment and personnel safety.
  • Develop and synchronize site functions transition through four distinct construction phases (design, build, qualify, validate).
  • Maintain project compliance in accordance with the site quality management system.
  • Prioritize and guide engineering resources in the design of facility and equipment within budget.
  • Guide the specification and selection of manufacturing / utility equipment to support site facility/process needs; Work with operations, validation, process development and quality functions to provide support for the design, installation, start-up, validation and operation of facility and or process equipment.
  • Effectively manages contractors. Ensures adherence to safe work practices and guidelines.
  • While not executing projects, support site operations and process engineers.
  • Other duties as assigned.
The Candidate
  • Bachelor's Degree in Engineering Field Required. Master's Degree in Engineering or Business Field would be a plus.
  • 3+ years Engineering Project Management experience preferred.
  • Prior experience with pharmaceutical facility construction, equipment/facility qualification & validation preferred; Prior experience managing external vendors
  • Hands-on experience with a combination of process, controls, and equipment engineering is required; Change control and validation experience is critical.
  • Six Sigma / Lean Manufacturing / Professional Project Management skills preferred.
  • Individual may be required sit for extended periods. Specific vision requirements include reading of written documents and use of computer monitor screen frequently. Sustained sitting at desk or workstation with use of phones, computers and any other office equipment required for specified position. Static stance/standing as required. File/Folder storage with non-repetitive light weight lifting, reaching and forward bending as necessary. Infrequent lifting overhead reaching less than or equal to 15 lbs. with the ability to potentially be able to lift up to 35 lbs and push/pull 40 lbs.
Why You Should Join Catalent
  • Several Employee Resource Groups focusing on D&I
  • Tuition Reimbursement - Let us help you finish your degree or earn a new one
  • Generous 401K match
  • 152 hours accrued PTO + 8 paid holidays
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.

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