Technical Transfer Engineer

2 weeks ago

Morrisville, United States Disability Solutions Full time

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 is a global, high-growth, public company, and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives. 

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 needed
  • Create and revise standard operating procedures for production, as well as create and revise procedures for new equipment and batch manufacturing
  • Create and revise master batch records, and assemble batch related documentation and complete reviews prior to transfer to quality assurance
  • Assist 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 teams
  • Work with Product Development to develop process knowledge for new processes as it relates to manufacturing and technical operations
  • Assist 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 workflow
  • Identify process deficiencies and recommend corrective improvements
  • All other duties as assigned;

The Candidate

  • High School Diploma or GED required, Associates Degree or Bachelors Degree is strongly preferred
  • One 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 GED
  • Prior experience working with Nasal Pharmaceutical Manufacturing Operations, Dry Powder Inhalation Processes, and Sterile Operations is strongly preferred
  • Experience with manufacturing operations including Cleaning, Compounding, Filling, Inspection and Assembly Operations is preferred
  • Experience in Clinical and Commercial Operations preferred
  • Knowledge of validation principles, manufacturing processes, quality systems, engineering design fundamentals, regulatory expectations, and industry trends is strongly preferred
  • Experience working in an FDA-regulated industry and knowledge of cGMPs, GAMP & 21 CFR part 11 validation requirements is preferred
  • On 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 holidays
  • Several Employee Resource Groups focusing on D&I
  • Dynamic, fast-paced work environment
  • Positive working environment focusing on continually improving processes to remain innovative
  • Potential 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.

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