Senior Process Engineer

What You’ll DoAs 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 hands-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.How You’ll ContributeLead 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 timelines, and support project delivery.Promote safe engineering practices, proper use of personal protective equipment, and compliance with Environmental, Health, and Safety (EHS) requirements.Provide technical support to Metrology and Calibration teams to establish appropriate equipment operating ranges and calibration job plans.Support Manufacturing and Facilities with equipment troubleshooting, including occasional off-hours support, to minimize downtime and improve process reliability.What It TakesYou’re an experienced process engineer who enjoys solving complex technical problems and translating engineering concepts into practical manufacturing solutions. You understand the importance of process control, equipment reliability, validation, and regulatory compliance in a cGMP environment. You’re comfortable leading cross-functional projects, managing competing priorities, and working independently while building strong partnerships across the organization.What You BringBachelor’s degree in Chemical Engineering, Mechanical Engineering, or a related engineering discipline.5–8 years of experience in a cGMP-regulated environment.Experience with medical device and drug product manufacturing and packaging equipment and processes.Experience with aseptic manufacturing, including applicable requirements under ISO 13408 and EU GMP Annex 1.Demonstrated expertise in material, equipment, and process validation in accordance with medical device and pharmaceutical industry standards.Strong equipment and process troubleshooting and problem-solving skills.Excellent written and verbal communication skills, including the ability to present technical information to large groups and management.Ability to manage time effectively, prioritize competing workloads, and deliver results independently.Strong collaboration and project management skills, with the ability to coordinate multidisciplinary teams and external partners.Commitment to safety, quality, continuous improvement, integrity, and delivering results.Nice to HaveMaster’s degree in Chemical Engineering, Mechanical Engineering, or a related field.Familiarity with FDA requirements, ISO 13485, and EU Medical Device Regulation (MDR) requirements for medical devices.Proficiency with statistical analysis software, statistical methods, and data-driven process improvement techniques.Experience with formulation and filling processes for viscous solutions.Experience with industrial automation platforms such as Rockwell Automation, Ignition, Siemens, Wonderware, or Modicon.Experience supporting scale-up and technology transfer from R&D into manufacturing.Familiarity with Enterprise Resource Planning (ERP) and Manufacturing Execution Systems (MES).Experience developing and implementing process improvements using Lean, Six Sigma, or similar methodologies.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, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.