Process Engineer II
What You’ll DoThe Process Engineer II supports process improvement 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 and engineering methods to optimize processes, troubleshoot issues, and support projects aligned with corporate goals.How You’ll ContributeSupport the design, specification, and implementation of equipment and systems in alignment with cGMP and other applicable standards. Identify and implement opportunities for process efficiency, cost reduction, standardization, and automation using Lean and Six Sigma principles. Support development of URS and FDS documents and assist with FAT/SAT activities. Support equipment qualification (IOQ, PQ) and process validation (PV), including testing, documentation, and regulatory support. Participate in process and product risk assessments and support validation deliverables. Support supplier evaluation and selection of materials meeting required technical and regulatory standards. Draft and update operating procedures and support training for manufacturing personnel. Support investigation of non-conformances and execution of NCR and CAPA activities. Collaborate with validation, manufacturing, R&D, QA, RA, facilities, IT, and external vendors on cross-functional projects. Support safety practices and ensure compliance with EHS requirements in all engineering activities. Provide technical support for equipment troubleshooting, calibration, and metrology-related activities, including off-hours support when needed. Support scale-up and tech transfer activities from development into manufacturing. Utilize project management tools (e.g., MS Project) to support execution of engineering projects. What It TakesThe Process Engineer II works on moderately complex engineering and process problems requiring evaluation of multiple variables. The role applies structured engineering judgment and regulatory knowledge to ensure compliant and efficient manufacturing systems.What You BringBachelor’s degree in Chemical Engineering, Mechanical Engineering, or related field. 2–5 years in a cGMP-regulated environment. Experience in medical device or pharmaceutical manufacturing preferred. Experience with process, equipment, and material validation in regulated environments. Strong troubleshooting and problem-solving skills. Working knowledge of FDA, ISO 13485, and EU MDR requirements. Experience with statistical analysis tools and methods. Experience with scale-up, tech transfer, and manufacturing process development. Familiarity with automation platforms (Rockwell, Siemens, Ignition, Wonderware, Modicon). Familiarity with ERP and MES systems. Strong communication skills and ability to work cross-functionally. Ability to manage time effectively and work collaboratively in a fast-paced environment. Strong personal attributes: integrity, accountability, and results orientation. Compensation & BenefitsThe 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.