Senior Process Engineer

Role Summary

The Process Engineer III leads diverse process improvement initiatives and process development projects for medical devices and drug products. Acting as a technical lead on multi-disciplinary teams, this role designs, purchases, validates, and implements equipment and systems that support cGMP-compliant manufacturing. The engineer applies strong analytical skills to solve complex problems, optimize processes, and ensure timely, effective decisions that align with corporate goals.

Responsibilities

• Lead the design and specification of equipment and systems in alignment with cGMP and other relevant standards.
• Identify opportunities for cost reduction and process efficiency improvements through standardization and automation.
• Develop and manage projects consistent with department and corporate objectives.
• Collaborate with suppliers to evaluate, select, and validate cost-effective raw materials that meet industry standards.
• Use methodologies such as Six Sigma and Lean to implement process improvements.

• Collaborate with validation teams to ensure equipment and processes meet commissioning and qualification requirements.
• Develop and maintain: User Requirement Specifications (URS), and Functional Design Specifications (FDS).
• Support FAT/SAT activities and documentation for process equipment and systems.
• Test equipment and materials; develop and validate processes to support regulatory approval and new product introduction.
• Support the development of equipment qualification (IOQ, PQ) and process validation (PV) protocols.
• Perform process/product risk assessments and prepare reports according to company procedures.

• Draft operating procedures for new equipment and processes; work with Document Control to finalize and implement through the document mastering process.
• Develop and edit material master part specifications and artwork specifications to meet requirements.
• Lead the initiation, investigation, implementation and closure of NCRs and CAPA relating to processes and process equipment.

• Interact with multiple internal departments and external vendors to coordinate multidisciplinary tasks.
• Lead and participate in project teams, ensuring alignment with regulatory and operational requirements utilizing project management tools such as MS Project.
• Develop strong partnerships with validation, facilities, manufacturing, R&D, QA, RA, IT enabling efficient and high value deliverables from all company functions.

• Promote safety awareness and ensure proper use of protective equipment in all engineering activities and ensure compliance with EHS standards.
• Provide technical support to metrology and calibration teams to deploy assets with effective process ranges and calibration job plans.
• Support manufacturing and facilities with equipment troubleshooting, at times off-hours, to reduce maintenance time and increase process reliability.

Qualifications

• Education: Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related field.
• Experience: 5–8 years in a cGMP-regulated environment.
• Experience with medical device manufacturing and packaging equipment/processes.
• Demonstrated expertise in material, equipment, and process validation per medical device and pharmaceutical industry standards.
• Desired Skills: Master’s degree in Chemical or Mechanical Engineering or related field.
• Excellent equipment and process troubleshooting skills.
• Strong communication skills (written and verbal), including ability to present to large groups and management.
• Familiarity with FDA, ISO 13485, and EU MDR compliance for medical devices.
• Proficiency with statistical analysis software and techniques.
• Experience with processes such as formulation and filling for viscous solutions, aseptic manufacturing, or fiber extrusion and carding.
• Experience with terminal sterilization (steam, gamma, VHP and EtO).
• Ability to manage time effectively, prioritize workload, and deliver results autonomously.
• Strong personal values: honesty, integrity, people development, and drive for results.
• Experience with automation platforms such as Rockwell Automation, Ignition, Siemens, Wonderware and Modicon.
• Experience supporting scale-up and tech transfer from R&D to manufacturing.
• Familiarity with ERP and MES systems.