Engineer II, MS&T - On The Floor - Severn Maryland

Company: Disability Solutions
Location: Severn, Maryland
Posted On: 02/06/2025

The Engineer II, Manufacturing, Sciences, and Technology (MS&T) will support GMP manufacturing operations as the floor supports rapid response of manufacturing operation in upstream, downstream and drug product. On-The-Floor Engineer is actively engaged with the manufacturing team in resolving process related issues an provide immediate resolution in collaboration with quality assurance or a cross functional team. 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.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 role:

• Support GMP manufacturing operation as the MS&T Process SME and point of contact for Client person in plant (PIP) on the floor in one or more of the following areas: cell culture, purification and/or fill & finish processes.
• Provide rapid response to manufacturing issues by initiating Emergency change control
• Serve as team liaison for process and product investigations and author investigation reports.
• Participate in manufacturing daily Tier and closely follow manufacturing schedule to identify critical process step where priority support is needed.
• Participating in Deviation triage by providing recommendation of immediate path forward in conjunction with on the Floor QA.
• Author and revise documents, Master Production Records and SOPs to support GMP manufacturing projects.
• Investigate process non conformances to determine root cause by following a problem solve methodology
• Implement Corrective and preventive action on the shop floor
• Real time review equipment parameters during process on the floor and anticipate risk of deviationThe candidate:
  • B.S. Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 3-6 years of experience in the pharmaceutical, (Upstream or downstream) 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.
  • Proficient with process modeling software such as SuperPro, JMP, MATLAB, Aspen a plus.
  • Proficient with Microsoft tools (Words, Excel, Project, PowerBI)The anticipated salary range for this position in Maryland is $93,000 to $128,000 plus an annual bonus target. 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:
    • Competitive medical benefits and 401K
    • 152 hours PTO + 8 Paid Holidays
    • Dynamic, fast-paced work environment
    • 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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