Technology Transfer Engineer
Company: Disability Solutions
Location: Morrisville
Posted on: May 8, 2024
Job Description:
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
- Work with engineering to develop equipment process parameters
and process workflow for new manufacturing processes
- 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
- Assist engineering to develop manufacturing equipment
improvements, quality improvements, and line performance
improvements;
- Identify process deficiencies and recommend corrective
improvements
- All other duties as assigned;The Candidate
- Associates Degree is requires, Bachelors Degree is strongly
preferred
- 3 or more years of related experience with a Bachelors Degree,
or 5 or more years of related experience with an Associates
Degree
- Prior experience required working with Nasal Pharmaceutical
Manufacturing Operations, Dry Powder Inhalation Processes, and
Sterile Operations
- Experienced with Tablet Operations including: Dispensing,
Compression, Coating, and Encapsulation
- Strong written and verbal communication skills
- Working knowledge of cGMPS
- Strong analytical reasoning skills, as well as root cause
analysis and problem solving
- Able to write, read, understand, and interpret technical
instructions
- Individual may be required to sit, stand, walk regularly and
occasionally lift 0-15 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--
- Competitive salary with bonus potential--
- Community engagement and green initiatives--
- Generous 401K match--and Paid Time Off accrual--
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--- Let us help you finish your degree or
earn a new one!
- GymPass program to promote overall physical wellness--
- Perkspot - offers exclusive or private discounts from
approximately 900+ merchants in a wide array of categoriesCatalent
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.--Catalent is committed to the health and safety of its
employees, visitors and the customers and patients we serve. As a
result of the global pandemic, we have modified many of our
recruitment and on-boarding processes to maintain everyone's
safety. The Human Resources teams will communicate all necessary
safety processes and procedures throughout each
stage.------personal initiative. dynamic pace. meaningful
work.Visit 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 . 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 .
Keywords: Disability Solutions, Fayetteville , Technology Transfer Engineer, IT / Software / Systems , Morrisville, North Carolina
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