Senior Process Engineer

What You'll Do

The 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 Contribute

• Lead the design and specification of equipment and systems in alignment with cGMP and other relevant standards
• Identify opportunities for cost reduction and process efficiency improvements through standardization and automation
• Develop and manage projects consistent with department and corporate objectives
• Collaborate with suppliers to evaluate, select, and validate cost-effective raw materials that meet industry standards
• Use methodologies such as Six Sigma and Lean to implement process improvements
• Collaborate with validation teams to ensure equipment and processes meet commissioning and qualification requirements
• Develop and maintain User Requirement Specifications (URS) and Functional Design Specifications (FDS)
• Support FAT/SAT activities and documentation for process equipment and systems
• Test equipment and materials and support process validation activities for regulatory approval and new product introduction
• Support development of equipment qualification (IQ/OQ/PQ) and process validation (PV) protocols
• Perform process and product risk assessments and prepare reports according to company procedures
• Draft and update operating procedures for new equipment and processes
• Develop material and artwork specifications
• Lead NCR and CAPA investigations related to processes and equipment
• Coordinate with internal departments and external vendors on multidisciplinary activities
• Lead and participate in project teams using MS Project or similar tools
• Partner with Validation, Facilities, Manufacturing, R&D, QA, RA, and IT teams
• Promote safety awareness and ensure compliance with EHS standards
• Provide technical support to metrology and calibration teams and assist with troubleshooting equipment issues, including off-hours support when needed

What It Takes

The 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 Bring

• Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related field
• 5-8 years in a cGMP-regulated environment
• Experience with medical device manufacturing and packaging equipment/processes
• Demonstrated expertise in material, equipment, and process validation per medical device and pharmaceutical industry standards

Nice to Have

• Master's degree in Chemical or Mechanical Engineering or related field
• Strong equipment and process troubleshooting skills
• Strong written and verbal communication skills, including presentation experience
• Familiarity with FDA, ISO 13485, and EU MDR compliance for medical devices
• Statistical analysis experience using software tools
• Experience with formulation and filling processes, aseptic manufacturing, or fiber extrusion and carding
• Experience with terminal sterilization (steam, gamma, VHP, EtO)
• Ability to manage time effectively and work independently
• Strong values: honesty, integrity, and results orientation
• Experience with automation platforms (Rockwell, Ignition, Siemens, Wonderware, Modicon)
• Experience supporting scale-up and tech transfer from R&D to manufacturing
• Familiarity with ERP and MES systems

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.