Associate Process Engineer, MS&T

Biontech Ag - Gaithersburg, MD

Part-time - Entry Level

Gaithersburg, MD

Professional, Scientific, and Technical Services

About the position

As an Associate Process Engineer in the MS&T (Manufacturing Science and Technology) team at BioNTech, you will play a crucial role in supporting the development and manufacturing of cell therapy products at our Gaithersburg, MD facility. This position is designed for individuals who are eager to apply their engineering knowledge in a laboratory setting, particularly within a highly regulated GMP (Good Manufacturing Practice) environment. You will report directly to the Engineer II of MSAT and will be involved in various lab studies, including process characterization and mixing model simulations. Your contributions will be essential in ensuring the smooth operation of lab activities and the successful manufacturing of innovative therapies aimed at combating serious diseases. In this role, you will be expected to apply basic engineering principles to identify and solve issues while also evaluating opportunities for process improvements. You will conduct routine tasks as directed, utilizing experimental, modeling, and engineering techniques to support lab operations. Effective communication skills are vital, as you will need to build strong working relationships within a technical team. Additionally, you will be required to demonstrate good problem-solving abilities to troubleshoot issues and escalate them as necessary. This position mandates on-site work as an essential function, emphasizing the importance of hands-on involvement in the lab environment. Your responsibilities will include learning to work compliantly in a GMP environment, supporting the planning, ordering, and stocking of lab supplies and equipment, and developing computational fluid dynamic (CFD) modeling simulations. You will also support and document laboratory experiments and studies aimed at characterizing equipment and processes, perform basic analytical testing, and assist with manufacturing deviations and investigations as needed. This role offers a unique opportunity to contribute to cutting-edge research and development in the field of immunotherapy, while also fostering your professional growth in a dynamic and innovative company.

Responsibilities

• Apply basic engineering principles to solve issues and evaluate opportunities for process improvements.
• Conduct routine tasks as directed using experimental, modeling, and engineering techniques.
• Support lab operations and manufacturing of cell therapy products.
• Learn to work compliantly in a highly regulated GMP environment.
• Support planning, ordering, and stocking of lab supplies and equipment.
• Learn and develop CFD (computational fluid dynamic) modeling simulations.
• Support and document laboratory experiments and studies to characterize equipment and processes.
• Perform basic analytical testing.
• Support manufacturing deviations and investigations as necessary.

Requirements

• Willing to work in a laboratory environment.
• Requires a Bachelor's degree in a chemistry/biology/engineering discipline; Master's degree preferred but not required; MBA with science/engineering background welcome.
• Excellent communication, interpersonal, and collaboration skills.
• Strong organizational, problem-solving, and project management skills.
• Willingness to think outside of the box and adapt best practices in a constantly evolving environment.

Nice-to-haves

• Prior experience with Pharma/Biopharma process development/quality/manufacturing preferred, but not required.
• Proficient knowledge of manufacturing processes, CMC requirements, process technologies, and regulatory requirements.
• Experience with process monitoring tools and strategies.
• Experience with change control, deviation management, investigations, and CAPAs.

Benefits

• Medical, Dental and Vision Insurance
• Life, AD&D, Critical Illness Insurance
• Pre-tax HSA & FSA, DCRA Spending Accounts
• Employee Assistance & Concierge Program (EAP) available 24/7
• Parental and Childbirth Leave & Family Planning Assistance
• Sitterstream: Virtual Tutoring & Childcare Membership
• Paid Time Off: Vacation, Sick, Bereavement, Holidays (including Floating) & Year-End U.S. Shutdown
• 401(K) Plan with Company Match
• Tuition Reimbursement & Student Loan Assistance Programs
• Wellbeing Incentive Platforms & Incentives
• Professional Development Programs
• Commuting Allowance and subsidized parking
• Discounted Home, Auto & Pet Insurance