Senior Process Engineer

cb074853-6382-48d7-9fef-316f4f5a88f7•Bedford, MA

20h•$122,000 - $152,000•Hybrid

About The Position

The Senior Process Engineer leads process development, equipment implementation, and process improvement initiatives for Anika’s medical device and drug product manufacturing operations. In a regulated manufacturing environment, the role develops, optimizes, validates, and implements equipment and processes to support safe, efficient, and cGMP-compliant manufacturing. The position serves as a technical lead on multidisciplinary projects, working with Manufacturing, Facilities, Validation, R&D, Quality Assurance, Regulatory Affairs, IT, and external vendors to address complex problems and bring products, equipment, and processes into production. The work combines hands-on engineering, technical project leadership, process validation, and continuous improvement. The position is based at Anika’s Bedford, Massachusetts facility and is primarily on-site, with some flexibility for hybrid work depending on project and operational needs.

Requirements

Bachelor’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, including the ability to coordinate multidisciplinary teams and external partners.
Commitment to safety, quality, continuous improvement, integrity, and delivering results.

Nice To Haves

Master’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.

Responsibilities

Lead process development and improvement initiatives, including equipment and system design, specification, selection, purchasing, and implementation in accordance with cGMP and applicable industry standards.
Identify and implement cost reduction, efficiency, standardization, and automation opportunities 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 on equipment commissioning, qualification, and process validation, including development of IOQ, PQ, and 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 related 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 and partner with Document Control to finalize and implement controlled documentation.
Develop and revise material master part specifications and artwork specifications to meet applicable requirements.
Lead initiation, investigation, implementation, and closure of process- and equipment-related Nonconformance Reports (NCRs) and Corrective and Preventive Actions (CAPAs).
Lead and participate in multidisciplinary project teams, coordinating internal stakeholders and external vendors to meet technical, regulatory, and operational requirements.
Build cross-functional partnerships with Manufacturing, Facilities, Validation, R&D, Quality Assurance, Regulatory Affairs, IT, and other teams.
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 requirements.
Provide technical support to Metrology and Calibration teams to establish 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.