6243 - Downstream Principal CQV Engineer / Lead Validation Engineer

Downstream Principal CQV Engineer / Lead Validation Engineer

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

Requirements:

• 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

Responsibilities:

• Downstream System Leadership
• Serve as the commissioning and qualification lead for Downstream systems
• Specific experience with chromatography systems, TFF filtration systems, viral filtration systems, and UFDF filtration systems

C&Q Lead Responsibilities:

• Commissioning and Qualification Documentation
• Gain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications
• Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES)
• Engage with design engineers and SMEs to clarify system intent and operational requirements
• Ensure alignment with quality, automation, and engineering teams on critical parameters and documentation
• Create Commissioning Test Plans that translate design intent into testable steps
• Collaborate with SMEs to ensure system requirements are accurately reflected in test plans
• Develop Installation, Operational, and Qualification (IOQ) protocols
• Prepare and submit summary reports documenting commissioning and qualification activities

System Ownership and Execution:

• Take custody of the system post-construction and maintain ownership through C&Q completion
• Perform Lockout/Tagout (LOTO) for system safety
• Conduct pre-startup safety checks and risk assessments
• Prepare daily pre-task plans and verify team readiness for safe execution
• Attend daily commissioning meetings to coordinate activities
• Execute commissioning and IOQ protocols
• Resolve issues arising during execution
• Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required

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

Salary Range:

• National (US) Range: $107,800 - $168,011 USD

Note: Verista is an equal opportunity employer.