Senior Process Engineer - cGMP Automation & Validation

Anika Therapeutics, Inc.; Bedford (MA); On-site; USD 122,000 - 152,000; Full time

Benefits offered by this job

Discretionary bonus program

Healthcare benefits

401(k) with company match

Employee stock purchase plan

Job summary

Anika Therapeutics, Inc. is seeking a Senior Process Engineer to lead process development and improvements for medical device and drug product manufacturing at our Bedford, MA site.

You will drive equipment selection, qualification, and process validation while partnering with Manufacturing, Validation, Quality, Regulatory, and IT to ensure cGMP compliance. We expect 5–8 years in a cGMP environment, with expertise in aseptic manufacturing and process validation.

Qualifications

• Bachelor’s degree in Chemical Engineering or related field.
• 5–8 years of experience in a cGMP-regulated environment.
• Experience with medical device and drug product manufacturing and packaging equipment.
• Experience with aseptic manufacturing per ISO 13408 and EU GMP Annex 1.
• Demonstrated expertise in validation and process improvement in medical device/pharma settings.

Responsibilities

• Lead process development and improvement initiatives, including equipment and system implementation in ctGMP settings.
• Collaborate with cross-functional teams to optimize manufacturing performance.
• Support IOQ, PQ, and PV protocol development and validation activities.
• Develop URS and FDS for process equipment and systems.
• Assist FAT/SAT and related documentation and training.
• Lead NCRs and CAPAs related to processes and equipment.

Skills

Process development

cGMP compliance

Project management

Cross-functional collaboration

Troubleshooting

Validation

Aseptic manufacturing

Equipment expertise

Analytical skills

Education

Bachelor's degree in Chemical Engineering

Master's degree in Chemical/Mechanical Engineering

Tools

Rockwell Automation

Siemens

Ignition

Wonderware

Modicon

Job description

Anika Therapeutics, Inc. is seeking a Senior Process Engineer to lead process development and improvements for medical device and drug product manufacturing at our Bedford, MA site.

You will drive equipment selection, qualification, and process validation while partnering with Manufacturing, Validation, Quality, Regulatory, and IT to ensure cGMP compliance. We expect 5–8 years in a cGMP environment, with expertise in aseptic manufacturing and process validation.