Process/Operations Engineer

We are seeking a Process/Operations Engineer to support manufacturing operations, equipment troubleshooting, process optimization, and capital projects.
Under general supervision, the engineer will apply basic engineering principles to resolve technical issues, support system improvements, and collaborate with cross-functional teams to enhance equipment performance and process efficiency.
This role is ideal for a hands-on professional with experience in a regulated GMP environment.
Responsibilities: Provide solutions to technical problems of moderate scope and complexity Evaluate, select, and apply standard engineering techniques under general supervision Complete technical assignments with defined objectives and limited variables Initiate and complete routine engineering tasks, documentation, and reports Troubleshoot equipment and systems to resolve performance issues Support daily operations as needed to meet schedule and resolve process challenges Audit equipment/system performance and ensure regulatory compliance Collaborate with manufacturing, quality, facilities, validation, and utilities teams to develop and implement system modifications Support capital projects under the supervision of project managers Assist in the design and construction of equipment or facility modifications Interface with consultants, architects, and engineering firms on design documentation Develop basic project cost estimates and schedules Source and evaluate quotes for equipment installation and modifications Skills and Competencies: Strong analytical and problem-solving skills Technical report writing and documentation Verbal and written communication skills Understanding of validation protocol writing and execution Computer literacy and ability to work with specialized equipment/software Ability to manage change and adapt to evolving technical challenges Self-motivated with excellent learning agility and the ability to leverage technology Requirements Qualifications: Master's degree in Engineering OR Bachelor's degree in Engineering and 2+ years of relevant experience Preferred disciplines: Chemical, Mechanical, or Electrical Engineering Preferred Qualifications: Experience in a GMP-regulated manufacturing or engineering environment Knowledge of pharmaceutical or biotech production processes Familiarity with validation, GLP/GMP, and regulated documentation Strong troubleshooting ability for manufacturing equipment (valves, pumps, utility systems) Experience with control systems (input/output/control logic), PLCs, and automation Background in drug substance/API operations Equipment start-up and commissioning experience