MS&T Engineer III

MS&T Engineer I/II

• 100% on-site

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 home to Catalents Inhalation franchise including product development clinical and commercial manufacturing for pMDI DPI and Nasal Sprays.

The MS&T Engineer I/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 Engineers 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. These functions will be executed following standard operating procedures and batch records in accordance with FDA and EU requirements and current Good Manufacturing Practices.

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.
• Author manufacturing investigations and complete CAPA assignments.
• 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.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.

The candidate:

• Bachelors degree in Engineering Pharmacy Chemistry or related field required.
• Minimum 4-6 years of experience of technical support and technical transfer in a non-sterile pharmaceutical manufacturing environment
• Working knowledge of cGMP requirements related to non-sterile drug product manufacturing processes.
• Excellent verbal communication written communication documentation negotiation critical thinking analytical problem solving detail orientation organization and time management skills required.
• Working knowledge of US/EU regulations is preferred.

Why you should join Catalent:

• Competitive medical benefits and 401K
• 152 hours PTO 8 Paid Holidays
• Dynamic fast-paced work environment
• Opportunity to work on Continuous Improvement Processes

Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7000 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 . 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 for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.