Senior Process Engineer

Purpose / Summary

The Process Engineer III 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.

Key Responsibilities

Process Development & Improvement

• 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.

Commissioning, Validation & Compliance

• 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; develop and validate processes to support regulatory approval and new product introduction.
• Support the development of equipment qualification (IOQ, PQ) and process validation (PV) protocols.
• Perform process/product risk assessments and prepare reports according to company procedures.

Documentation & Compliance

• Draft operating procedures for new equipment and processes; work with Document Control to finalize and implement through the document mastering process.
• Develop and edit material master part specifications and artwork specifications to meet requirements.
• Lead the initiation, investigation, implementation and closure of NCRs and CAPA relating to processes and process equipment.

Cross-Functional Collaboration

• Interact with multiple internal departments and external vendors to coordinate multidisciplinary tasks.
• Lead and participate in project teams, ensuring alignment with regulatory and operational requirements utilizing project management tools such as MS Project.
• Develop strong partnerships with validation, facilities, manufacturing, R&D, QA, RA, IT enabling efficient and high value deliverables from all company functions.

Safety and Technical Support

• Promote safety awareness and ensure proper use of protective equipment in all engineering activities and ensure compliance with EHS standards.
• Provide technical support to metrology and calibration teams to deploy assets with effective process ranges and calibration job plans.
• Support manufacturing and facilities with equipment troubleshooting, at times off-hours, to reduce maintenance time and increase process reliability.

Qualifications & Experience

Education:

Bachelor's degree in Chemical Engineering, Mechanical Engineering, or related field.

Experience:

• 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.

Desired Skills:

• Master's degree in Chemical or Mechanical Engineering or related field.
• Excellent equipment and process troubleshooting skills.
• Strong communication skills (written and verbal), including ability to present to large groups and management.
• Familiarity with FDA, ISO 13485, and EU MDR compliance for medical devices.
• Proficiency with statistical analysis software and techniques.
• Experience with processes such as formulation and filling for viscous solutions, aseptic manufacturing, or fiber extrusion and carding
• Experience with terminal sterilization (steam, gamma, VHP and EtO).
• Ability to manage time effectively, prioritize workload, and deliver results autonomously.
• Strong personal values: honesty, integrity, people development, and drive for results.
• Experience with automation platforms such as Rockwell Automation, Ignition, Siemens, Wonderware and 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.