Downstream CQV Lead Engineer | GMP Validation Expert

Veristainc; Holly Springs (NC); On-site; USD 100,000 - 130,000; Full time

Benefits offered by this job

High growth potential

Company-paid Disability Insurance

401(k) Retirement Plan

Tuition Reimbursement

Paid Parental Leave

Job summary

Veristainc in Holly Springs, NC is seeking a Downstream Principal CQV Engineer to lead the commissioning and qualification of downstream systems. The ideal candidate will have over 10 years of CQV experience in GMP-regulated pharmaceutical environments and a Bachelor's degree in Engineering or related fields.

You will be responsible for developing specifications, leading cross-functional collaboration, and ensuring compliance with project requirements. Benefits include competitive pay, medical insurance, and a 401(k) plan with employer matching.

Qualifications

• 10+ years of CQV experience in GMP-regulated pharmaceutical environments.
• Ability to work independently and in cross-functional teams.
• Strong communication and organizational skills.

Responsibilities

• Serve as commissioning and qualification lead for downstream systems.
• Develop User Requirement Specifications and Quality Risk Assessments.
• Prepare and submit summary reports documenting commissioning activities.

Skills

CQV experience in GMP-regulated environments

Hands-on experience with downstream bioprocess equipment

Strong understanding of validation lifecycle documentation

Collaboration with cross-functional teams

Excellent documentation skills

Education

Bachelor’s degree in Engineering, Life Sciences or Biotechnology

Tools

Digital validation systems such as Kneat

Job description

Veristainc in Holly Springs, NC is seeking a Downstream Principal CQV Engineer to lead the commissioning and qualification of downstream systems. The ideal candidate will have over 10 years of CQV experience in GMP-regulated pharmaceutical environments and a Bachelor's degree in Engineering or related fields.

You will be responsible for developing specifications, leading cross-functional collaboration, and ensuring compliance with project requirements. Benefits include competitive pay, medical insurance, and a 401(k) plan with employer matching.