6244 - CIP (Clean-in-Place) CQV Engineer / Lead Validation Engineer

United States·Escondido,Apexlead

OtherQA & TestingValidation Engineer

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Quick Summary

Overview

Description Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs.

Requirements Summary

Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related technical discipline Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments Hands-on experience with CIP systems and…

Technical Tools

documentation

Description

We empower and support our colleagues
We commit to client success at every turn
We have the courage to do the right thing
We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
We constantly acquire new skills and learn from our experiences to enhance our collective expertise

We are seeking a Clean-in-Place (CIP) CQV Engineer with hands-on experience overseeing the commissioning and qualification of Clean-In-Place (CIP) systems. This role ensures that all systems are designed, tested, and documented in alignment with project requirements and safety standards.

Responsibilities

~1 min read

Serve as the commissioning and qualification (C&Q) lead for CIP systems (responsibilities described below).
Develop and optimize CIP cleaning cycles to meet operational and quality standards.
Supervise the safe introduction and handling of caustic solutions during cleaning cycle development.

Requirements

~3 min read

Gain a thorough understanding of system design by reviewing engineering documentation, P&IDs, and design specifications.
Develop User Requirement Specifications (URS) and Quality Risk Assessment for Equipment and Automated Systems (QRAES).
Engage with design engineers and SMEs to clarify system intent and operational requirements.
Ensure alignment with quality, automation, and engineering teams on critical parameters and documentation.
Create Commissioning Test Plans that translate design intent into testable steps.
Coordinate with the Automation Team to incorporate all automation functional testing.
Collaborate with SMEs to ensure system requirements are accurately reflected in test plans.
Develop Installation, Operational, and Qualification (IOQ) protocols.
Prepare and submit summary reports documenting commissioning and qualification activities.

Bachelor’s degree in Engineering, Biotechnology, Life Sciences, or a related technical discipline
10+ years of role-specific experience
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

For US geography, the salary range for this position is shown below. The actual salary is dependent upon a variety of job-related factors such as professional background, training, work experience, location, business needs, market demand, and competitive market practice. Therefore, in some circumstances, the actual salary could fall outside of this expected range. This salary range is subject to change and may be modified in the future.

*Verista is an equal opportunity employer.

National (US) Range

$107,800—$168,011 USD

Benefits

Why Choose Verista?

High growth potential and fast-paced organization with a people-focused culture
Competitive pay plus performance-based incentive programs
Company-paid Life, Short-Term, and Long-Term Disability Insurance.
Medical, Dental & Vision insurances
FSA, DCARE, Commuter Benefits
Supplemental Life, Hospital, Critical Illness and Legal Insurance
Health Savings Account
401(k) Retirement Plan (Employer Matching benefit)
Paid Time Off (Rollover Option) and Holidays
As Needed Sick Time
Tuition Reimbursement
Team Social Activities (We have fun!)
Employee Recognition
Employee Referral Program
Paid Parental Leave and Bereavement

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For more information about our company, please visit us at Verista.com

Take custody of the system post-construction and maintain ownership through C&Q completion.
Perform Lockout/Tagout (LOTO) for system safety.
Conduct pre-startup safety checks and risk assessments.
Prepare daily pre-task plans and verify team readiness for safe execution.
Attend daily commissioning meetings to coordinate activities.
Execute commissioning and IOQ protocols.
Resolve issues arising during execution.
Participate in Factory Acceptance Tests (FATs) and Site Acceptance Tests (SATs) as required.