6242 - Upstream Principal Engineer / Lead Validation Engineer

The role

The Upstream Principal Engineer oversees the commissioning and qualification of Upstream systems. This role ensures systems are designed, tested, and documented according to project requirements and safety standards.

What you will do

• Serve as the commissioning and qualification lead for Upstream systems
• Review engineering documentation, P&IDs, and design specifications
• Develop User Requirement Specifications and Quality Risk Assessment
• Create Commissioning Test Plans
• Coordinate with the Automation Team for functional testing
• Develop Installation, Operational, and Qualification protocols
• Prepare and submit summary reports
• Perform Lockout/Tagout for system safety
• Conduct pre-startup safety checks and risk assessments
• Execute commissioning and IOQ protocols

Required qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical discipline
• 10+ years of role specific experience
• Experience supporting CQV activities in GMP-regulated pharmaceutical or biotechnology environments
• Hands-on experience with downstream bioprocess equipment and purification systems
• Strong understanding of validation lifecycle documentation (IQ/OQ/PQ, protocols, reports)
• Ability to work independently while collaborating with cross-functional teams
• Strong documentation, organizational, and communication skills
• Experience with digital validation systems such as Kneat
• Experience supporting FAT/SAT, commissioning, and equipment startup
• Familiarity with risk-based validation approaches
• Experience in biologics manufacturing or monoclonal antibody production environments

Benefits

• 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
• Employee Recognition

About the company

Verista's 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The company provides innovative solutions and services to empower growth and innovation within the scientific community.