6243 - Downstream Principal Engineer / Lead Validation Engineer

Downstream Principal CQV Engineer

We are seeking a Downstream Principal CQV Engineer to oversee the commissioning and qualification of downstream systems, ensuring alignment with project requirements and safety standards.

Responsibilities

• Serve as commissioning and qualification lead for downstream systems (chromatography, TFF, viral filtration, UFDF).
• Review engineering documentation, P&IDs, and design specifications to grasp system design.
• Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems.
• 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, incorporating automation functional testing.
• Develop Installation, Operational, and Qualification protocols.
• Prepare and submit summary reports documenting commissioning and qualification activities.
• Take custody of the system post-construction and maintain ownership through C&Q completion.
• Perform Lockout/Tagout (LOTO), pre-startup safety checks, risk assessments, and daily pre-task plans.
• Attend daily commissioning meetings, execute protocols, and resolve issues.
• Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required.

Requirements

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related discipline.
• 10+ years of CQV experience 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 and collaborate with cross‑functional teams.
• Excellent 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.
• Onsite location requirement: Holly Springs, NC.

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).
• Paid Time Off (Rollover Option) and Holidays.
• As Needed Sick Time.
• Tuition Reimbursement.
• Team Social Activities.
• Employee Recognition.
• Employee Referral Program.
• Paid Parental Leave and Bereavement.

*Verista is an equal opportunity employer.