Position Summary:

Catalent Pharma Solutions in Morrisville, NC is hiring a Technology Transfer Engineer for the Production group. The Production Group is responsible for the production of Nasal Inhalers, Dry Powder Inhalers, Tableting Operations, and Non-Sterile Liquids within the Catalent Morrisville site. The Technology Transfer Engineer supports the manufacturing of Phase 1, 2, and 3 for clinical supplies and commercial supplies, and works closely with Quality, Operations, and Product Development management.

This is a full-time position: Monday – Friday, 8:00AM – 5:00PM.

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.

The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.  

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

Perform investigations, write problem reports prior to QA review, write and complete CAPAs, deviations, and change controls, and interact with customers as neededCreate and revise standard operating procedures for production, as well as create and revise procedures for new equipment and batch manufacturingCreate and revise master batch records, and assemble batch related documentation and complete reviews prior to transfer to quality assuranceAssist in the NPI process for the technical transfer of new products/processes into the production facility, and act as the point-person for manufacturing on cross-functional NPI teamsWork with Product Development to develop process knowledge for new processes as it relates to manufacturing and technical operationsAssist in the creation of work instructions and job aids, and train manufacturing operators on the execution of new manufacturing processes as it relates to batch record documentation and process workflowIdentify process deficiencies and recommend corrective improvementsAll other duties as assigned;

The Candidate

High School Diploma or GED required, Associates Degree or Bachelors Degree is strongly preferredOne or more years of related experience required with a Bachelors Degree, two or more years of related experience required with an Associates Degree, or eight or more years of related experience required with a High School Diploma or GEDPrior experience working with Nasal Pharmaceutical Manufacturing Operations, Dry Powder Inhalation Processes, and Sterile Operations is strongly preferredExperience with manufacturing operations including Cleaning, Compounding, Filling, Inspection and Assembly Operations is preferredExperience in Clinical and Commercial Operations preferredKnowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations, and industry trends is strongly preferredExperience working in an FDA-regulated industry and knowledge of cGMPs, GAMP & 21 CFR part 11 validation requirements is preferredOn an average eight-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 the waist height, climb or balance, stoop, kneel, crouch or crawl; talk, hear and smell, and lift up to 40 pounds.

Why you should join Catalent:

Defined career path and annual performance review and feedback process Diverse, inclusive culture 152 hours of PTO + 8 paid holidaysSeveral Employee Resource Groups focusing on D&IDynamic, fast-paced work environmentPositive working environment focusing on continually improving processes to remain innovativePotential for career growth on an expanding team within an organization dedicated to preserving and bettering lives Community engagement and green initiatives Generous 401K match Medical, dental, and vision benefits effective day one of employment Tuition Reimbursement – Let us help you finish your degree or earn a new one!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 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.