Anika · 1 day ago
Senior Process Engineer
Bedford, MA
Full-time
Onsite
Senior Level
$150K/yr - $180K/yr
5+ years expAnika is a company focused on medical devices and drug products, and they are seeking a Senior Process Engineer to lead process improvement initiatives and development projects. This role involves designing, validating, and implementing equipment and systems in compliance with cGMP standards while collaborating with various teams to ensure efficiency and compliance in manufacturing processes.
BiotechnologyHealth CareManufacturingTherapeutics
Responsibilities
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; 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
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
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
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
Qualification
Required
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
Preferred
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
Benefits
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
Company
Anika
Anika is a global joint preservation company that creates and delivers meaningful advancements in early intervention orthopedic care.
201-500 employees
H1B Sponsorship
Anika has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (1)
2022 (1)
2021 (4)
Funding
Current Stage
Public CompanyTotal Funding
unknownKey Investors
Caligan Partners
2024-03-07Post Ipo Equity
1993-05-14IPO
Leadership Team
Cheryl Blanchard
President and CEO
Recent News
GlobeNewswire
2026-01-09
2026-01-09
2025-12-31
Company data provided by crunchbase