Engineering Technician

Brief Job Description

The Engineering Technician supports the Process Execution Team (PET) to deliver manufacturing performance in line with the manufacturing plan. This role leads technical troubleshooting for equipment used within the PET. As a skilled specialist working with limited supervision, individuals in this position self-generate and implement process improvement projects that support both short- and long-term area goals. This role interacts with Operators, PET Engineers, Area Leaders, Validation, PMO, and Quality while serving as the bridge between Manufacturing, Maintenance and PET Engineering.

Job Responsibilities

Technical troubleshooting and equipment performance

• Serve as the escalation point for complex, intermittent, and cross-system faults that are not resolved by standard maintenance procedures, applying structured problem solving and troubleshooting techniques to complete repairs and prevent recurrence.

• Use a variety of tools, testing and measuring equipment to complete emergency, corrective, and preventative maintenance on equipment and systems used within the PET.

• Monitor equipment and systems for performance and problem indicators, and act on early signs of degradation before they cause downtime.

Automation, controls, and data systems

• Work across the area's automation and data systems, including PLCs, SCADAs, HMIs, servers, databases, data historian, and visualization platforms.

• Troubleshoot PLC, I/O, and vision programs.

• Implement new PLC/HMI code and modify existing code under approved change control.

• Own the control system version control, backup, and restoration program for the area, and the associated data integrity and compliance requirements.

• Diagnose and resolve network issues affecting production equipment, including VLAN, subnet, and IP protocol faults.

• Analyze trends in equipment and process data to identify root causes, solutions, and improvements.

Process improvement

• Identify and implement continuous improvement projects in changeover reduction, yield improvement, OEE improvement, maintenance reliability, and waste reduction.

• Develop project justification and engineering proposals, providing input for the capital planning process.

• Participate in new equipment design, providing input for the development of User Requirements, Specifications, and documentation required to qualify new equipment and processes.

• Serve as a project resource for new equipment installations, retrofits, and upgrades, and assist with executing validation protocols for equipment and processes.

Quality, compliance, and documentation

• Lead and coordinate technical investigations and studies, and support deviation investigations with technical assessment of equipment and system contribution.

• Execute all maintenance and technical work in accordance with SOPs, cGMPs, and OSHA safety requirements, and document it to cGMP standards.

• Complete documentation and required functions within the work order system, and maintain compliance with established MRO procedures for inventory control.

Knowledge transfer

• Train Operators and Maintenance Technicians on systems, software, equipment, machines, procedures, and processes.

• Provide technical guidance to Operators and Technicians on shift when equipment or system issues arise.

Experience & Education

Minimum Qualifications

• Demonstrated experience maintaining and improving automated production equipment in a regulated (cGMP or comparable) manufacturing environment.

• Experience and knowledge of ladder logic, with the ability to navigate PLC programs to isolate faults.

• Demonstrated ability to lead troubleshooting on automated production equipment and drive an issue to root cause.

• Training in mechanics, hydraulics, pneumatics, electronics, and the use of testing equipment for electrical and mechanical troubleshooting.

• Experience with Computerized Maintenance Management Systems such as SAP, including work order documentation and established MRO procedures for inventory control.

• Ability to read and interpret diagrams, drawings, P&IDs, electrical schematics, and other technical documentation.

• Ability to self-direct daily work based on an understanding of area business need, and to make independent decisions within the scope of the role, escalating novel or cross-functional issues to the Area Leader or PET Engineer.

• Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language.

Preferred Qualifications

• Associate degree in engineering or a related discipline, or equivalent mechanical trade school graduate.

• 3+ or more years of experience with automated production equipment.

• Experience with OEE, TPM, LEAN, or other continuous improvement systems.

• Experience in biologics or sterile drug product manufacturing.

• Experience with data historian, SCADA, or visualization platform configuration.

Physical & Work Environment

• Ability to lift and handle equipment change parts, tooling, and materials associated with equipment maintenance and repair.

• Ability to stand, walk, bend, kneel, climb ladders, and work in confined or elevated spaces for extended periods across a 12-hour shift.

• Ability to wear gowning, sterile garments, and Personal Protective Equipment (PPE) as required by specific activities and classified area requirements.

• Work in and around operating production equipment, cleanrooms and classified environments, mechanical spaces, and utility areas.

• Exposure to noise, temperature variation, cleaning agents, and process materials consistent with a cGMP biologics manufacturing facility.