Lead Process Engineer, Devens, MA- Onsite

Lead Process Engineer

This role requires the ability to be on-site, Devens, MA

Responsibilities:

Lead/Provide technical support for CIP/SIP, ensuring processes operate safely, efficiently, and in compliance with cGMP regulations

Lead or support process improvement and scale-up projects

Conduct process investigations, identify root causes, and implement corrective/preventive actions to resolve manufacturing issues

Develop and optimize process parameters to achieve consistent product quality and yield

Prepare and review process documentation including batch records, SOPs, validation protocols/reports, and change control documents

Collaborate with cross-functional teams (R D, Quality, Validation, Maintenance, and Production) to ensure successful technology transfer and process validation

Support equipment qualification and process validation activities for new or modified equipment/processes

Analyze production data, generate reports, and recommend process or equipment improvements to enhance performance and efficiency

Ensure compliance with all safety and regulatory requirements within the manufacturing environment

Requirements:

Bachelor s Degree or equivalent required (STEM degree, Biomedical Engineering, Chemical Engineering preferred)

7-10 years of relevant Validation Experience within pharma / biologics

Minimum 5 years of Cleaning Validation experience to include:

1. Hands-on experience taking rinse and swab samples and performing visual inspection

2. Experience developing CIP and SIP cycles for process piping, transfer panels, and bioreactors

3. Experience developing load patterns for autoclaves and parts / glass washers

4. Experience with Delta V automation for CIP / SIP

5. Hands on experience executing Riboflavin studies

Experience using Ellab ValSuite Pro and ValGenesis systems preferred