Downstream CQV Lead Engineer for Biopharma Systems

Verista; Holly Springs (NC); On-site; USD 108,000 - 168,000; Full time

Benefits offered by this job

Competitive pay plus performance-based

Company-paid Insurance: Life, STD, LTD

Medical, Dental & Vision Insurance

401(k) with employer match

Paid Time Off and Holidays

Tuition Reimbursement

Team Social Activities

Employee Recognition

Employee Referral Program

Paid Parental Leave and Bereavement

Job summary

Verista is seeking a Downstream Principal Engineer to oversee commissioning and qualification of downstream systems in a GMP-biopharma environment. You will lead C&Q activities, review engineering docs, develop URS/QRAES, IOQ, and test plans while coordinating with design engineers and SMEs.

Role requires 10+ years of CQV experience, hands-on downstream equipment knowledge, and strong documentation. Onsite in Holly Springs, NC with competitive pay and comprehensive benefits.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical discipline.
• 10+ years of role-specific experience in CQV for GMP-regulated biotech/pharma.
• Hands-on experience with downstream bioprocess equipment and purification systems.
• Strong documentation, organizational, and communication skills.
• Experience with FAT/SAT, commissioning and equipment startup.

Responsibilities

• Oversee commissioning and qualification of downstream systems.
• Lead C&Q activities and ensure alignment with project requirements and safety standards.
• Develop URS, QRAES, IOQ protocols, test plans, and summary reports.
• Collaborate with design engineers, SMEs, automation teams, and QA to ensure testability and traceability.
• Provide system ownership post-construction and manage risk-based validation approaches.
• Support FAT/SAT and site acceptance tests as required.

Skills

CQV experience

Independent working

Documentation skills

Validation lifecycle

Kneat experience

FAT/SAT exposure

Risk-based validation

Biologics manufacturing know-how

Downstream equipment

Education

Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical discipline

Tools

Kneat

Job description

Verista is seeking a Downstream Principal Engineer to oversee commissioning and qualification of downstream systems in a GMP-biopharma environment. You will lead C&Q activities, review engineering docs, develop URS/QRAES, IOQ, and test plans while coordinating with design engineers and SMEs.

Role requires 10+ years of CQV experience, hands-on downstream equipment knowledge, and strong documentation. Onsite in Holly Springs, NC with competitive pay and comprehensive benefits.