Upstream CQV Principal Engineer & Validation Lead

Verista; Holly Springs (NC); On-site; USD 101,000 - 168,000; Full time

Benefits offered by this job

Health Insurance

401(k) Retirement Plan

Paid Time Off

Tuition Reimbursement

Life Insurance

Disability Insurance

Job summary

Verista is hiring an Upstream Principal Engineer in Holly Springs, NC, to lead commissioning and qualification of Upstream systems including chromatography and filtration platforms. You will develop URS, QRAES, and IOQ protocols, and coordinate with design engineers and SMEs to ensure compliant, well-documented system validation.

The role requires 10+ years in CQV or related environments, strong documentation, and hands-on experience with bioprocess equipment.

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 IQ/OQ/PQ validation lifecycle documentation.
• 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.
• Onsite job requirement in Holly Springs, NC.

Responsibilities

• Serve as the commissioning and qualification lead for Upstream systems.
• Review engineering documentation, P&IDs, and design specifications.
• Develop URS and Quality Risk Assessment for Equipment and Automated Systems.
• Coordinate with design engineers and SMEs to clarify system intent.
• Create Commissioning Test Plans and IOQ protocols.
• Collaborate with Automation Team to incorporate testing.
• Prepare summary reports documenting commissioning activities.
• Take custody of systems post-construction through C&Q completion.
• Participate in FATs and SATs.

Skills

Independent work

Cross-functional collaboration

Strong documentation

Communication skills

Risk-based validation

Education

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

Tools

Kneat

Job description

Verista is hiring an Upstream Principal Engineer in Holly Springs, NC, to lead commissioning and qualification of Upstream systems including chromatography and filtration platforms. You will develop URS, QRAES, and IOQ protocols, and coordinate with design engineers and SMEs to ensure compliant, well-documented system validation.

The role requires 10+ years in CQV or related environments, strong documentation, and hands-on experience with bioprocess equipment.