Manufacturing, Science and Technology Engineer II

Catalent Pharma Solutions • Morrisville, NC • 9h ago

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.

The Role:

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

The Candidate:

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

Working knowledge of US/EU regulations is preferred

Why you should join Catalent:

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.

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .

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