Manufacturing, Science and Technology Engineer II

Catalent Pharma Solutions•Morrisville, NC

19h•Onsite

About The Position

Manufacturing, Science and Technology Engineer II Position Summary: Work Schedule: Monday - Friday, 8:00am to 5:00pm 100% on-site The Morrisville (MSV) facility is Catalent’s center of excellence for nasal product development and manufacturing, providing end‑to-end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing. The MS&T Engineer II is accountable for driving results in a fast-paced environment by providing technical support for clinical and commercial non-sterile drug product manufacturing. The MS&T Engineer’s responsibilities include but are not limited to the following: performing tech transfers of new processes and technologies into the site, preparation of documentation to support process validation and batch manufacturing, troubleshooting manufacturing processes, completing process deviations and investigations, and writing reports and coordinating lab studies with the formulation development lab.

Requirements

Must have Bachelors Degree in Engineering, Pharmacy, Chemistry or related field
Minimum of 4-6 years’ experience in technical support and technical transfer in a non-sterile pharmaceutical manufacturing environment is required
Working knowledge of cGMP requirements related to non-sterile drug product manufacturing processes is required
Proficiency in MS Office Word, Excel and Outlook
Ability to interreact with internal stakeholders and external customers is required

Nice To Haves

Working knowledge of US/EU regulations is preferred

Responsibilities

Provides technical assistance for tech transfer and validation efforts for assigned manufacturing projects
Write Master Batch Records with a strong understanding of equipment, critical process parameters, in-process tests, etc
Monitors manufacturing processes during production runs to assess any technical process issues and provides troubleshooting support as needed
Composes process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols
Identifies specific parameters, sampling, and tests used in the validation protocols of new and existing products
Interact with clients during routinely scheduled project meetings
Other duties as assigned

Benefits

Defined career path and annual performance review and feedback process
Diverse, inclusive culture
Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
152 hours of PTO + 8 paid holidays
Generous 401K match
Medical, dental and vision benefits
Tuition Reimbursement - Let us help you finish your degree or start a new degree!
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.