Anika · 4 hours ago
Process Engineer II
Bedford, MA, US
Full-time
Onsite
Entry, Mid Level
$90K/yr - $120K/yr
2+ years expAnika is a company focused on medical devices and drug products, and they are seeking a Process Engineer II to support process improvement initiatives and process development projects. The role involves designing, validating, and implementing equipment and systems for cGMP-compliant manufacturing, as well as applying analytical skills to optimize processes and troubleshoot issues.
BiotechnologyHealth CareManufacturingTherapeutics
Responsibilities
Support 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
Contribute to 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
Assist in developing User Requirement Specifications (URS) and Functional Design Specifications (FDS)
Support FAT/SAT activities and documentation for process equipment and systems
Conduct testing of equipment and materials; assist in process validation activities 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 and update operating procedures for equipment and processes and assist with training of manufacturing personnel
Assist with material part specifications and artwork specifications
Investigate manufacturing non-conformances and implement effective solutions through the NCR and CAPA processes
Interact with multiple internal departments and external vendors to coordinate multidisciplinary tasks
Participate in project teams, ensuring alignment with regulatory and operational requirements utilizing project management tools such as MS Project
Build collaborative relationships with validation, facilities, manufacturing, R&D, QA, RA, and IT teams
Promote safety awareness and 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
2–5 years in a cGMP-regulated environment
Proficient with material, equipment, and process validation per medical device and pharmaceutical industry standards
Strong equipment and process troubleshooting skills
Good communication skills (written and verbal)
Understanding of FDA, ISO 13485, and EU MDR compliance
Proficient with statistical analysis techniques and software
Ability to manage time effectively and work collaboratively
Strong personal values: honesty, integrity, and drive for results
Preferred
Experience with medical device manufacturing or pharmaceutical processes
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)
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
Company data provided by crunchbase