Process Engineer

Process Engineer

The Process Engineer will be the technical representative on cross functional projects within the Media plant. The Process Engineer will investigate technical issues, including but not limited to designing and executing experiments, working with Manufacturing to manufacture pilot lots, product testing, etc to determine root cause of the issue and implement robust corrective actions. The Process Engineer will review proposed engineering / manufacturing process changes and assess the risk of these changes to the product.

The Process Engineer will assess any raw material suggested changes throughout the Media plant and work with the team to determine feasibility of the change.

Duties and Responsibilities:

• Utilize learned or existing skills and knowledge to investigate and troubleshoot short and long-term manufacturing and/or technical product issues.
• Lead projects or be an integral member of project teams tasked with resolving technical issues or continuous improvement projects utilizing Six Sigma and Lean Manufacturing
• Develop and execute workable project plans and timelines to successfully lead project teams to meet goals.
• Collect, record, report and interpret data in a manner consistent with QSR, ISO and GMP guidelines.
• Present data and results to team members and leadership orally and in writing.
• Interact with others including Scientific Operations, Quality, Engineering, Manufacturing, Sales and Marketing and other functions within the Company and with external customers, vendors and suppliers.

Minimum Qualifications:

• Experience working with microorganisms and microbiological media is required.
• Successful project management experience is required.
• Experience in problem solving and troubleshooting is required.
• Pharmaceutical and/or medical device industry experience is preferred.
• Excellent communication skills and computer skills including Word, Excel, and PowerPoint required.
• Experience with processes including fluid dispense and filling, lyophilization, and sterilization is a plus.
• Six Sigma training or knowledge preferred.
• Green Belt or Black Belt certification is a plus.
• This role is in-office in Hunt Valley, MD.

Education:

• B.S. in Microbiology or Biology or related science with 2+ years of related experience or Advanced Degree in related science with 1+ years of related experience.