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 WindowViewer), 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.
Qualifications:
- 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, SolidWorks, 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.
ADA-These Requirements are a Condition of Employment:
- 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.
