Senior Process Engineer

What You’ll DoThe Senior Process Engineer leads diverse process improvement initiatives and process development projects for medical devices and drug products. Acting as a technical lead on multi-disciplinary teams, this role designs, purchases, validates, and implements equipment and systems that support cGMP-compliant manufacturing. The engineer applies strong analytical skills to solve complex problems, optimize processes, and ensure timely, effective decisions that align with corporate goals.How You’ll ContributeLead the design and specification of equipment and systems in alignment with cGMP and other relevant standardsIdentify opportunities for cost reduction and process efficiency improvements through standardization and automationDevelop and manage projects consistent with department and corporate objectivesCollaborate with suppliers to evaluate, select, and validate cost-effective raw materials that meet industry standardsUse methodologies such as Six Sigma and Lean to implement process improvementsCollaborate with validation teams to ensure equipment and processes meet commissioning and qualification requirementsDevelop and maintain User Requirement Specifications (URS) and Functional Design Specifications (FDS)Support FAT/SAT activities and documentation for process equipment and systemsTest equipment and materials and support process validation activities for regulatory approval and new product introductionSupport development of equipment qualification (IQ/OQ/PQ) and process validation (PV) protocolsPerform process and product risk assessments and prepare reports according to company proceduresDraft and update operating procedures for new equipment and processesDevelop material and artwork specificationsLead NCR and CAPA investigations related to processes and equipmentCoordinate with internal departments and external vendors on multidisciplinary activitiesLead and participate in project teams using MS Project or similar toolsPartner with Validation, Facilities, Manufacturing, R&D, QA, RA, and IT teamsPromote safety awareness and ensure compliance with EHS standardsProvide technical support to metrology and calibration teams and assist with troubleshooting equipment issues, including off-hours support when neededWhat It TakesThe job requires the ability to work on diverse complex issues where analysis of situations or data requires an in-depth evaluation of a variety of factors. The position exercises broad judgment in selecting optimum methods, techniques, and evaluation criteria for obtaining results.What You BringBachelor’s degree in Chemical Engineering, Mechanical Engineering, or related field5–8 years in a cGMP-regulated environmentExperience with medical device manufacturing and packaging equipment/processesDemonstrated expertise in material, equipment, and process validation per medical device and pharmaceutical industry standardsNice to HaveMaster’s degree in Chemical or Mechanical Engineering or related fieldStrong equipment and process troubleshooting skillsStrong written and verbal communication skills, including presentation experienceFamiliarity with FDA, ISO 13485, and EU MDR compliance for medical devicesStatistical analysis experience using software toolsExperience with formulation and filling processes, aseptic manufacturing, or fiber extrusion and cardingExperience with terminal sterilization (steam, gamma, VHP, EtO)Ability to manage time effectively and work independentlyStrong values: honesty, integrity, and results orientationExperience with automation platforms (Rockwell, Ignition, Siemens, Wonderware, Modicon)Experience supporting scale-up and tech transfer from R&D to manufacturingFamiliarity with ERP and MES systemsThe 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.