Downstream CQV Lead Engineer for Biopharma Systems

Verista; Holly Springs (NC); Vor Ort; USD 108.000 - 168.000; Vollzeit

Benefits dieser Stelle

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

Zusammenfassung

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.

Qualifikationen

• 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.

Aufgaben

• 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.

Kenntnisse

CQV experience

Independent working

Documentation skills

Validation lifecycle

Kneat experience

FAT/SAT exposure

Risk-based validation

Biologics manufacturing know-how

Downstream equipment

Ausbildung

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

Tools

Kneat

Jobbeschreibung

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.