LVI Associates · 3 weeks ago
Senior Process Engineer / Lead Process Engineer
Devens, MA
Full-time
Onsite
Senior Level, Lead/Staff
$85K/yr - $150K/yr
7+ years expLVI Associates partners with leading brands in the life sciences industry to drive growth and innovation in healthcare. The Senior Process Engineer will provide technical leadership for CIP/SIP processes, conduct investigations for manufacturing issues, and collaborate with cross-functional teams to ensure compliance and optimize production processes.
RecruitingService IndustryStaffing Agency
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
Qualification
Required
Bachelor's degree or equivalent
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
Ability to work on-site full-time in Devens, MA
Preferred
STEM preferred; Biomedical or Chemical Engineering ideal
Familiarity with Ellab ValSuite Pro and ValGenesis systems preferred
Benefits
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
FSA, DCARE, commuter benefits
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
Tuition reimbursement
Team social activities
Employee recognition and referral programs
Paid parental leave and bereavement
Company
LVI Associates
LVI Associates is a recruitment agency for infrastructure and engineering.
1001-5000 employees
Funding
Current Stage
Late StageRecent News
IEEE Spectrum
2025-03-21
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