MS&T Engineer I​/II

Overview

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 supports product development, launch, and full life-cycle supply with time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing. The RTP facility houses Catalent's Inhalation franchise for product development, clinical and commercial manufacturing of 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. Responsibilities include, but are not limited to:

• Provide 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.
• Monitor manufacturing processes during production runs to assess technical process issues and provide troubleshooting support as needed.
• Author manufacturing investigations and complete CAPA assignments.
• Compose process validation documentation, including CQA assessment, pFMEA risk assessment, and process validation protocols.
• Identify specific parameters, sampling, and tests used in the validation protocols of new and existing products.
• Interact with clients during routinely scheduled project meetings.
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements.

• Bachelor’s degree in Engineering, Pharmacy, Chemistry, or related field required.
• Minimum 4–6 years of experience in 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 and written communication, documentation, negotiation, critical thinking, analytical, problem-solving, attention to detail, organization, and time management skills.
• Working knowledge of US/EU regulations is preferred.

• 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 7,000 life-saving and life-enhancing products to patients around the world. 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 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 emailing Disabili and including the job number, title and location. 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 routed to a local recruiter who will assist to ensure appropriate consideration in the application or hiring process.

Notice to Agency and Search Firm Representatives:
Catalent Pharma Solutions is not accepting unsolicited resumes from agencies or search firms for this job posting. Resumes submitted by third party agencies without a valid signed search agreement may be considered the property of Catalent. No fee will be paid if a candidate is hired as a result of an unsolicited agency referral.

Important Security Notice to U.S. Job Seekers:
Catalent NEVER asks candidates for payments or highly sensitive information during the offer process. If you receive such requests, do not respond and forward them to  for investigation with local authorities.

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