Verista · 3 days ago
6041 - Senior Process Engineer / Lead Process Engineer
Devens, MA
Full-time
Onsite
Senior Level, Lead/Staff
$85K/yr - $150K/yr
7+ years expVerista is a company that collaborates with leading brands in the life sciences industry to address critical healthcare challenges. The Lead Process Engineer will be responsible for providing technical support for CIP/SIP processes, leading process improvement projects, and ensuring compliance with regulatory requirements while collaborating with cross-functional teams.
ComplianceHealth CareLife ScienceManufacturingPharmaceutical
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
Qualification
Required
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:
Hands-on experience taking rinse and swab samples and performing visual inspection
Experience developing CIP and SIP cycles for process piping, transfer panels, and bioreactors
Experience developing load patterns for autoclaves and parts / glass washers
Experience with Delta V automation for CIP / SIP
Hands on experience executing Riboflavin studies
Preferred
Experience using Ellab ValSuite Pro and ValGenesis systems
Benefits
High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement
Company
Verista
Verista offers transformative compliance, automation, packaging solutions for the life sciences, pharmaceutical and manufacturing.
501-1000 employees
H1B Sponsorship
Verista has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (7)
2024 (4)
2023 (13)
2022 (6)
2021 (1)
Funding
Current Stage
Late StageLeadership Team
Bill Murray
Chief Financial Officer
Dan White
Chief Operating Officer
Recent News
2023-12-22
2023-12-22
Company data provided by crunchbase