Process Control Engineer

Process Control Engineer AmbioPharm, Inc. - 2.4 North Augusta, SC Job Details 3 days ago Qualifications USP standards Pharmaceutical regulatory compliance Drug regulation

Full Job Description 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 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.