Senior Process Engineer - cGMP Process Leader

Anika; Bedford (MA); Hybrid; USD 120,000 - 180,000; Full time

Benefits offered by this job

Discretionary bonus

Healthcare benefits

Health savings account

401(k) with company match

Employee stock purchase plan

Paid time off

Long-term incentives

Job summary

Anika seeks a Senior Process Engineer in Bedford, MA to lead process development, equipment implementation, and continuous improvement for medical device and drug product manufacturing. The role collaborates across Manufacturing, Validation, QA, Regulatory, IT, and vendors to drive projects from concept through validation and production.

You will develop URS/FDS, support FAT/SAT, and apply Lean/Six Sigma to enhance efficiency, quality, and reliability in a regulated environment.

Qualifications

• Bachelor’s degree in Chemical Engineering, Mechanical 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 and processes.
• Experience with aseptic manufacturing and related standards.
• Demonstrated expertise in material, equipment, and process validation.
• Strong troubleshooting and problem-solving skills.
• Excellent written and verbal communication, ability to present to management.

Responsibilities

• Lead process development and improvement initiatives, including equipment selection and implementation in a cGMP context.
• Identify cost reduction and efficiency opportunities to improve manufacturing performance.
• Manage engineering projects aligned with departmental priorities.
• Collaborate with suppliers to evaluate and validate materials meeting requirements.
• Apply Lean, Six Sigma, and statistical methods to optimize processes.
• Support equipment commissioning, qualification, and process validation (IOQ, PQ, PV).
• Develop URS and FDS for equipment and systems.
• Support FAT, SAT, and related documentation.
• Lead NCRs and CAPAs for processes and equipment.
• Coordinate cross-functional teams and external partners for project delivery.

Skills

Process engineering

cGMP

Lean Six Sigma

Project management

Cross-functional collaboration

Analytical skills

Communication skills

Education

Bachelor’s degree in Chemical or Mechanical Engineering

Tools

Microsoft Project

ERP systems

MES

Rockwell Automation

Siemens

Wonderware

Job description

Anika seeks a Senior Process Engineer in Bedford, MA to lead process development, equipment implementation, and continuous improvement for medical device and drug product manufacturing. The role collaborates across Manufacturing, Validation, QA, Regulatory, IT, and vendors to drive projects from concept through validation and production.

You will develop URS/FDS, support FAT/SAT, and apply Lean/Six Sigma to enhance efficiency, quality, and reliability in a regulated environment.