Engineer III, MST

Engineer III, Manufacturing Science and Technology (MS&T) Position Summary Catalent Cell & Gene Therapy is a growing Contract Development and Manufacturing Organization (CDMO) with an internationally recognized tradition of quality and service.
Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to industry leaders as well as innovative start-ups utilizing novel technologies to produce state-of-the-art vaccines and therapies for people when they are most in need.
As a Catalent employee, you will actively contribute to the delivery of our services and products to our customers and their patients.
The Engineer III, Manufacturing Science and Technology role is critical to our patients.
The Engineer III in MS&T is responsible for accurately transferring the process from the client and process development to manufacturing with patient safety in mind, executing with efficiency always.
Quality, safety and on-time delivery is a must to be successful in this role! This position will support Manufacturing Operations in the successful transfer and startup of clinical drug substance and drug product cGMP manufacturing operations at Catalent.
The MS&T Engineer III is actively engaged in the technical transfer of client and Catalent Process Development information for implementation of cGMP processes.
The individual will serve as a subject matter expert (SME) for biologic Upstream Processes and/or Downstream Processes.
Success in this position requires the ability to work hands on in a cleanroom, and the ability to collaborate in a cross-functional, fast paced environment.
This is a fulltime position working Days; Monday – Friday; The position will provide support for both both the BioPark and BWI sites.
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: Partner with GMP manufacturing and Process Development project teams as the MS&T project lead & SME in one or more of the following areas: cell culture, purification and/or fill & finish processes.
Serve as team leader for process and product investigations and author investigation reports.
Act as MS&T tech transfer project leader from both Catalent Process Development and external clients into GMP manufacturing.
Author tech transfer documents, Master Production Records and SOPs to support GMP manufacturing projects.
Working closely with Program Management to ensure MS&T project milestones are achieved attending reoccurring and adhoc meetings as required.
Collect and trend process data for external (client) and internal review.
Assist with training GMP Manufacturing staff on Client processes.
Evaluate and recommend equipment and disposable systems for client projects.
Perform facility fit assessments, process modeling, and CPV statistical analysis.
The Candidate: B.
S.
Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 4-8 years of experience in the pharmaceutical or biotechnology industry -OR- M.
S.
Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 2+ years of experience Knowledge/expertise relevant to protein and virus manufacturing in a cGMP environment.
Experience in one or more of the following manufacturing areas: cell and/or microbial culture, protein purification and fill/finish.
Experience with process modeling software such as SuperPro, JMP, MatLab, Aspen a plus.
Experience in a CMO environment or in a similar client-customer based work environment a plus.
Why You Should Join Catalent Competitive medical benefits and 401K 152 hours of 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 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 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 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.
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