Process Control Engineer

Process Controls Engineer

Primary Responsibilities:

• Identify manufacturing process improvement opportunities and implement automation to improve efficiency.
• Act as a subject matter expert for process and facility equipment operations, preventive maintenance, and repairs.
• Work in a cGMP environment to assess processes and interpret operational data.
• Troubleshoot and repair production equipment while coordinating with Facilities and external vendors.
• Create and maintain SOPs, engineering documentation, and electrical diagrams.
• Support maintenance and metrology teams through diagnostics and testing assistance.
• Assist equipment design and construction efforts through user requirements, utility requirements, and scale-up calculations.
• Train Facilities and Manufacturing personnel on equipment operation and maintenance.
• Maintain and improve site software used in GxP environments.
• Drive site digitization and software adoption initiatives.
• Maintain and improve custom-built software systems including BMS (Niagara), Tofflon (NetSCADA, InTouch Window Viewer), call-out systems, and related platforms.
• Manage multiple priorities while maintaining project timelines.
• Communicate effectively across departments and support weekend work when needed.
• Support the Engineering group and site.

• BS or MS in Engineering preferred, or an Associate degree with 5+ years of related experience in lieu of a bachelor’s degree.
• Knowledge of algorithms and programming logic.
• Minimum 3 years of experience working with process equipment.
• Proficiency in AutoCAD, Blender, Solid Works, or similar 2D/3D modeling software preferred.
• Python experience is highly desired but not required.
• Lyophilization experience preferred.
• Pharmaceutical industry experience with familiarity in cGMP regulations preferred.
• Familiarity with automated controls and pneumatic control systems preferred.
• Strong written and verbal communication skills.
• Demonstrated critical thinking and troubleshooting ability.
• Must have a firm understanding of cGMPs, USP, and regulatory guidance documents as it relates to the pharmaceutical industry.

• Must be able to push, pull, squat, stand and walk through-out the day
• Must be able to lift up to 20lbs
• Must be able to wear safety shoes & glasses through-out the day while in designated areas. (provided by the company)
• You must be cleared by a physician to wear a respirator throughout the day while in designated areas.
• Must be able work in a chemical environment.