Engineer II, MS&T

Catalent • Harmans, MD

1d • Onsite

About The Position

We have an opportunity for an Engineer II, MS&T to join our team and support GMP manufacturing operations as a project leader for clinical drug substance and drug product transfers. In this role, you will translate client and process development information into cGMP processes and act as a subject matter expert for biologic upstream and downstream processes. You will work hands-on in a cleanroom and collaborate in a fast-paced, cross-functional environment. This position offers the chance to make a real impact on delivering advanced therapies to patients in need.

Requirements

• Bachelor of Science in Chemical Engineering, Chemistry, Biology, Life Sciences or related field with 3-6 years of experience in the pharmaceutical or biotechnology industry, or Master of Science in these fields with 2+ years of experience.
• Knowledge and 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.
• On-site presence required, as the role involves time on the manufacturing floor and cross-functional collaboration.

Nice To Haves

• Experience with process modeling software such as SuperPro, JMP, MatLab, or Aspen is a plus.
• Experience in a Contract Manufacturing Organization environment or similar client-customer based work environment is a plus.

Responsibilities

• Partner with GMP manufacturing and Process Development teams as MS&T project lead and subject matter expert in areas such as cell culture, purification, and fill & finish processes.
• Serve as team leader for process and product investigations and author investigation reports.
• Lead MS&T technology transfer projects from Catalent Process Development and external clients into GMP manufacturing.
• Author technology transfer documents, Master Production Records, and Standard Operating Procedures to support GMP manufacturing projects.
• Work closely with Program Management to ensure MS&T project milestones are achieved, attending recurring and ad hoc meetings as required.
• Collect and trend process data for 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 Continued Process Verification statistical analysis.

Benefits

• Competitive paid time off plus 8 paid holidays.
• Medical, dental, and vision benefits effective day one of employment.
• Tuition reimbursement.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level