Lead CIP CQV Engineer for Clean-in-Place Validation

Verista, Inc.

Apex (NC)

On-site

USD 108,000 - 168,000

Full time

14 days+
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Benefits offered by this job

401(k) Retirement Plan (Employer Match
Health, Dental, Vision Insurance
Paid Time Off
Tuition Reimbursement
Employee Referral Program

Job summary

Verista is seeking a Clean‑in‑Place (CIP) CQV Engineer to lead commissioning and qualification of CIP systems in GMP environments. The role requires hands-on CIP expertise, IQ/OQ/PQ knowledge, and coordination with cross-functional teams to ensure project compliance and quality.

You will develop URS/QRAES, IOQ protocols, and test plans while owning the system post‑construction through CQV completion. Apex, NC onsite position offering competitive compensation and benefits.

Qualifications

  • Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related technical discipline
  • 10+ years of role-specific experience in CQV
  • Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments
  • Hands-on experience with CIP systems and automated cleaning processes
  • Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ protocols and reports)
  • Ability to work independently while coordinating with cross‑functional project teams
  • Strong technical documentation and communication skills
  • Experience using digital validation platforms such as Kneat
  • Experience supporting FAT/SAT, commissioning, and equipment startup
  • Familiarity with automated process systems and PLC-based equipment
  • Experience in biologics or large‑scale biopharmaceutical manufacturing environments
  • Onsite job requirement in Apex, NC

Responsibilities

  • Lead CIP and CQV activities for CIP systems ensuring design, testing and documentation meet project requirements
  • Develop CIP cleaning cycles and supervise safe handling of caustic solutions during cleaning cycle development
  • Review engineering docs, URS, and risk assessments; coordinate with design engineers and SMEs
  • Create IOQ, IQ/OQ/PQ protocols and commissioning test plans aligned with project needs
  • Support FATs/SATs and participate in risk assessments and safety checks

Skills

CQV Leadership
GMP Experience
Documentation Skills
Industrial Automation
Kneat

Education

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

Tools

Kneat

Job description

Verista is seeking a Clean‑in‑Place (CIP) CQV Engineer to lead commissioning and qualification of CIP systems in GMP environments. The role requires hands-on CIP expertise, IQ/OQ/PQ knowledge, and coordination with cross-functional teams to ensure project compliance and quality.

You will develop URS/QRAES, IOQ protocols, and test plans while owning the system post‑construction through CQV completion. Apex, NC onsite position offering competitive compensation and benefits.

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