Senior Process Engineer

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Bedford, MA, Bedford, MA, US

Salary Range: $ To $ Annually

As the Senior Process Engineer, you’ll lead process development, equipment implementation, and process improvement initiatives supporting Anika’s medical device and drug product manufacturing operations. Working in a regulated manufacturing environment, you’ll apply your engineering expertise to develop, optimize, validate, and implement equipment and processes that support safe, efficient, and cGMP-compliant manufacturing.

You’ll serve as a technical lead on multidisciplinary projects, partnering with Manufacturing, Facilities, Validation, R&D, Quality Assurance, Regulatory Affairs, IT, and external vendors to solve complex problems and bring new products, equipment, and processes into production. This role combines hand‑on engineering, technical project leadership, process validation, and continuous improvement, with opportunities to improve manufacturing efficiency, reliability, and product quality.

This position is based at Anika’s Bedford, MA facility and is primarily on‑site, with some flexibility for hybrid work depending on project and operational needs.

• Lead process development and improvement initiatives, including the design, specification, selection, purchase, and implementation of equipment and systems in accordance with cGMP and applicable industry standards.
• Identify and implement opportunities for cost reduction, process efficiency, standardization, and automation to improve manufacturing performance.
• Develop and manage engineering projects aligned with departmental priorities and corporate objectives.
• Collaborate with suppliers to evaluate, select, and validate cost‑effective raw materials that meet technical and industry requirements.
• Apply Lean, Six Sigma, statistical analysis, and other process improvement methodologies to optimize manufacturing processes.
• Partner with Validation to support equipment commissioning, qualification, and process validation activities, including the development of Installation/Operational Qualification (IOQ), Performance Qualification (PQ), and Process Validation (PV) protocols.
• Develop and maintain User Requirement Specifications (URS) and Functional Design Specifications (FDS) for process equipment and systems.
• Support Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and associated documentation.
• Test equipment and materials, develop and validate processes, and support regulatory approval and new product introduction activities.
• Conduct process and product risk assessments and prepare supporting documentation in accordance with company procedures.
• Develop operating procedures for new equipment and processes, partnering with Document Control to finalize and implement controlled documentation.
• Develop and revise material master part specifications and artwork specifications to meet applicable requirements.
• Lead the initiation, investigation, implementation, and closure of Nonconformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs) related to processes and process equipment.
• Lead and participate in multidisciplinary project teams, coordinating internal stakeholders and external vendors to deliver projects that meet technical, regulatory, and operational requirements.
• Develop strong cross‑functional partnerships with Manufacturing, Facilities, Validation, R&D, Quality Assurance, Regulatory Affairs, IT, and other teams to support effective project execution.
• Use project management tools, including Microsoft Project, to coordinate activities, manage…