Senior Process Engineer

Join to apply for the Senior Process Engineer role at Anika

$/yr - $/yr

• Lead design and specification of equipment and systems in alignment with cGMP and other relevant standards.
• Identify opportunities for cost reduction and process efficiency 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 Six Sigma and Lean methodologies 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 equipment qualification (IOQ, PQ) and process validation (PV) protocol development.
• Perform process/product risk assessments and prepare reports per company procedures.
• Draft operating procedures and work with Document Control to implement and master documents.
• Develop and edit material master part specifications and artwork specifications.
• Lead initiation, investigation, implementation, and closure of NCRs and CAPA.
• 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.
• Promote safety awareness and ensure compliance with EHS standards.
• Provide technical support to metrology and calibration teams.
• Support manufacturing and facilities with equipment troubleshooting to reduce maintenance time and increase reliability.

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

• Master’s degree in Chemical or Mechanical Engineering or related field.
• Excellent equipment and process troubleshooting skills.
• Strong communication skills (written and verbal), with 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, 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 (Rockwell Automation, Ignition, Siemens, Wonderware, Modicon).
• Experience supporting scale‑up and tech transfer from R&D to manufacturing.
• Familiarity with ERP and MES systems.

The role offers a competitive base salary, discretionary bonus program, comprehensive healthcare, HSA, 401(k) with company match, employee stock purchase plan, paid time off, and other long‑term incentives.

Mid‑Senior level

Full-time

Management and Manufacturing

Bedford, MA (or other U.S. locations available)