Senior Process Engineer​/Lead Process Engineer

Senior Process Engineer / Lead Process Engineer

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Base pay range: $85,000.00/yr - $/yr

Description

This organization partners with some of the most recognized brands in the life sciences industry to address complex business needs. Its mission is to drive growth and innovation within the scientific community, supporting researchers, organizations, and companies in solving critical healthcare challenges. The team delivers innovative solutions and services that enable informed decision‑making, backed by significant investment in people and capabilities.

Growth is fueled by exceptional professionals who thrive in collaborative environments and share a commitment to improving lives. These dedicated experts make an impact every day.

Culture & Values

• Empower and support colleagues
• Commit to client success at every turn
• Demonstrate courage to do the right thing
• Foster an inclusive environment where team members feel respected, engaged, and challenged
• Continuously acquire new skills and learn from experiences to enhance collective expertise

Lead Process Engineer Responsibilities

• Provide technical leadership for CIP/SIP processes, ensuring safe, efficient, and cGMP‑compliant operations
• Lead or support process improvement and scale‑up initiatives
• Conduct investigations, identify root causes, and implement corrective/preventive actions for manufacturing issues
• Develop and optimize process parameters to ensure 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, Production) for technology transfer and process validation
• Support equipment qualification and process validation for new or modified equipment/processes
• Analyze production data, generate reports, and recommend improvements to enhance performance and efficiency
• Ensure compliance with all safety and regulatory requirements in the manufacturing environment

Requirements

• Bachelor’s degree or equivalent (STEM preferred; Biomedical or Chemical Engineering ideal)
• 7–10 years of relevant validation experience in pharma/biologics
• Minimum 5 years of cleaning validation experience, including:
• Hands‑on experience with rinse and swab sampling and visual inspections
• Development of CIP and SIP cycles for process piping, transfer panels, and bioreactors
• Creation of load patterns for autoclaves and parts/glass washers
• Experience with Delta V automation for CIP/SIP
• Execution of Riboflavin studies
• Familiarity with Ellab Val Suite Pro and Val Genesis systems preferred
• Ability to work on‑site full‑time in Devens, MA

Compensation

National (US) Range: $85,000 – $150,000 USD

Actual salary depends on factors such as experience, training, location, and market conditions.

• High growth potential in a fast‑paced, people‑focused organization
• Competitive pay plus performance‑based incentives
• Company‑paid life, short‑term, and long‑term disability insurance
• Medical, dental, and vision coverage
• Supplemental life, hospital, critical illness, and legal insurance
• Health savings account
• 401(k) retirement plan with employer match
• Paid time off (with rollover option) and holidays
• Sick time as needed
• Team social activities
• Employee recognition and referral programs
• Paid parental leave and bereavement

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