Responsible for independently addressing equipment upgrades and improvements through process improvements and via the use of capital project execution. Responsible for design, construction, and maintenance of the plant control, electrical infrastructure systems, and process equipment. Performs electrical/controls design changes; design, build, and install upgrades via capital project execution. Consults vendors and equipment experts to formulate, design, and install equipment upgrades. Authors and provides technical support for developing processes and equipment documents including URS, DOE, Specifications, and validation documents.

Work Schedule: Monday - Friday 8:00am - 5:00pm. Ability to work off-shift when necessary.

• Provides technical discipline to implementation and maintenance of facility and process control systems, including troubleshooting automated systems and coding.
• Working with automation equipment vendors and our local users to develop solutions for managing and reporting process data.
• Assist in documenting user requirements for vendor bid packages and generate validation documents to confirm user requirements are met.
• Support equipment and facility operation to include PLC and database programming.
• Independently perform controls implementation and capital project execution in accordance with applicable engineering standards.
• Assess, implement, and revise engineering standards as needed.
• Ensure a safe and quality working environment through training, awareness, and compliance to safety guidelines and SOP's.
• Provide engineering support to manufacturing such as: installation of upgrades, new equipment installation, and assist in equipment troubleshooting.
• Provide engineering support to return equipment to service.
• Ensure the maintenance of their department, premises, and equipment
• Coordinates activities and documentation requirements associated with project execution such as; shutdown management, manufacturing coordination meetings, verification of production schedules, start-up activities, management of change documentation, and deviation authorization.
• Perform capital projects as assigned.
• Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).

• Bachelor of Science degree in Electrical Engineering or related field required.Work experience considered in lieu of degree.
• Eight years or more of relevant work experience required in capital project execution. Preferably in an FDA regulated environment, GMP facility.
• Manufacturing experience required, preferably in the pharmaceutical industry.
• Experience in project management accountability equal to or greater than $100,000.
• SQL programming experience.
• Progressive experience in pharmaceutical plant design and maintenance.
• Knowledge of pharmaceutical processing equipment and calibration/certification is highly desirable.
• Proficiency in applying Allen Bradley PLC's, HMI's, Robotics, Motor Controls, and sensors in industrial and production applications.
• Hands-on experience in the design, development, troubleshooting, and commissioning of electrical and electronic systems for industrial applications.
• Working knowledge of 480V/110V power distribution, Security Access, Smoke/Fire Alarm, and Building Management Systems.
• Six Sigma and Lean Manufacturing experience strongly preferred.
• Well-developed understanding of process control, process automation, and project management.
• Verifiable knowledge of and experience in application of cGMP's, validation, quality systems, document control and the impact of regulatory considerations on engineering initiatives.

Working Conditions:

• Willingness to work in plant producing radioactive materials and requiring all employees to participate in safety programs designed to minimize potential and/or actual exposure levels.
• Responsibilities include the ability to lift up to 70 pounds, kneeling, crouching, twisting the upper body, walking, bending, stooping, pushing, pulling, reaching, must be able to physically negotiate stairs and evacuation ladders with or without accommodation, wear and operate safety equipment, enter vessels, and inspect equipment.
• Material handling devices (e.g., hand truck, fork truck, and conveyors) are used when possible, however, use of proper lifting and movement techniques is necessary to prevent injury.
• Must be willing to wear a variety of Personal Protective Equipment (PPE) and hearing protection as needed.
• May be required to sit or stand for long periods of 8+ hours a day while performing duties.
• Must possess good hand-eye coordination; close attention to detail is required.
• Must be able to work indoors and outdoors with exposure to mechanical/moving parts, hazards including corrosive, flammable and toxic material, dust, dirt, odors, and irritants.
• Willingness to complete safety training within allotted timeframes, and work in a team-based environment.
• Must be able to work outside of regular work hours, including off shift, weekend, and holiday work as business needs require.