MSAT Engineer II - Severn Maryland

Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/07/2025

Engineer II, Manufacturing, Sciences, and Technology (MS&T)Catalent Pharma Solutions is looking to hire an Engineer II, Manufacturing, Sciences, and Technology (MS&T) to support our GMP Manufacturing Team in Harmans, MDCatalent, 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.Our FDA-licensed, state-of-the-art CGMP manufacturing facility for Gene Therapies is located on the Harmans/BWI campus. The campus, featuring two manufacturing facilities is located 5 miles from the Baltimore Washington International (BWI) airport and 13 miles from our--. The campus is close to Washington, DC's I-270 Technology Corridor, top universities, and government agencies.-- The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central services, testing labs, and a warehouse. The Harmans/BWI-2 facility, at approximately 145,000 sq. ft., is under development and will house 8 CGMP manufacturing suites and cold storage warehousing.The Engineer II, Manufacturing, Sciences, and Technology (MS&T) will support GMP manufacturing operations as a project leader in the successful transfer and startup of clinical drug substance and drug product. The Engineer II is actively engaged in the translation of client and Process Development information for implementation of cGMP processes. The individual will serve as a subject matter expert (SME) for biologic Upstream/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 full-time onsite position working Days; Monday - Friday, 8am-5pm and the position will provide support for both the BWI sites and BioPark.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.
• Other duties as assignedThe Candidate
  • B.S. in Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 3-6 years of experience in the pharmaceutical or biotechnology industry -OR-
  • M.S. in 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 is required.
  • Experience in one or more of the following manufacturing areas: cell and/or microbial culture, protein purification and fill/finish required.
  • 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.
  • On-site presence, as the role requires time on the manufacturing floor and cross-functional collaborationThe anticipated salary range for this position in Maryland is $93,280 to $128,260 plus an annual bonus, when eligible.The final salary offered to a successful candidate may vary, and will be dependent on several factors that may include but are not limited to: the type and length of experience within the job, type and length of experience within the industry, skillset, education, business needs, etc. Catalent is a multi-state employer, and this salary range may not reflect positions that work in other states.Why you should Join Catalent
    • Potential for career growth within an expanding team.
    • Defined career path and annual performance review & feedback process.
    • Cross-functional exposure to other areas within the organization.
    • Medical, Dental, Vision, and 401K are all offered from day one of employment.
    • 152 hours of PTO and 8 paid holidays.
    • Opportunity to work on Continuous Improvement ProcessesCatalent 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 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 spam@catalent.com for us to investigate with local authorities.California Job Seekers can find our California Job Applicant Notice . More...

          

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