Process Engineer II

Salary Range:$90,000.00 To $ Annually

The Process Engineer II supports process improvement initiatives and process development projects for medical devices and drug products. This role designs, validates, and implements equipment and systems that support cGMP-compliant manufacturing. The engineer applies analytical skills to optimize processes, troubleshoot issues, and contribute to projects aligning with corporate goals.

• Support 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.
• Contribute to 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.
• Assist in developing User Requirement Specifications (URS) and Functional Design Specifications (FDS).
• Support FAT/SAT activities and documentation for process equipment and systems.
• Conduct testing of equipment and materials; assist in process validation activities 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 and update operating procedures for equipment and processes and assist with training of manufacturing personnel.
• Assist with material part specifications and artwork specifications.
• Investigate manufacturing non-conformances and implement effective solutions through the NCR and CAPA processes.

• Interact with multiple internal departments and external vendors to coordinate multidisciplinary tasks.
• Participate in project teams, ensuring alignment with regulatory and operational requirements utilizing project management tools such as MS Project.
• Build collaborative relationships with validation, facilities, manufacturing, R&D, QA, RA, and IT teams.

• Promote safety awareness and 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.

Bachelor’s degree in Chemical Engineering, Mechanical Engineering, or related field.

• 2–5 years in a cGMP-regulated environment.
• Experience with medical device manufacturing or pharmaceutical processes preferred.
• Proficient with material, equipment, and process validation per medical device and pharmaceutical industry standards.

• Strong equipment and process troubleshooting skills.
• Good communication skills (written and verbal).
• Understanding of FDA, ISO 13485, and EU MDR compliance.
• Proficient with statistical analysis techniques and software.
• 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 and work collaboratively.
• Strong personal values: honesty, integrity, 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.

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position,…