Senior Process Engineer

Responsibilities: Lead process development and improvement initiatives for equipment and systems aligned with cGMP standards Specify, select, purchase, and implement equipment and systems Identify opportunities for cost reduction, efficiency, standardization, and automation Manage engineering projects and collaborate with suppliers for material validation Apply Lean, Six Sigma, and statistical methods to optimize processes Support validation activities (IOQ, PQ, PV) and develop URS and FDS Participate in FAT/SAT and document related activities Conduct risk assessments and prepare supporting documentation Develop operating procedures with Document Control and revise material/ artwork specifications Lead NCRs and CAPAs related to processes and equipment Coordinate multidisciplinary teams and external vendors to deliver projects Use Microsoft Project to manage timelines and deliverables Promote safe engineering practices and compliance with EHS requirements Provide technical support to Metrology and Calibration teams and assist with troubleshooting to minimize downtime

Key requirements: Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related field 5–8 years in a cGMP-regulated environment Experience with medical device and drug product manufacturing and packaging equipment Experience with aseptic manufacturing per ISO 13408 and EU GMP Annex 1 Proven expertise in process and equipment validation per industry standards Strong troubleshooting and problem-solving skills Excellent written and verbal communication, and ability to present to groups Ability to manage time, priorities, and deliver results independently Strong collaboration and project management skills Commitment to safety, quality, and continuous improvement collaboration problem-solving communication cGMP compliance process validation (IOQ/PQ/PV) URD/FDS development