Back to jobs

6078 - Senior CQV Engineer / Senior Validation Engineer

Holly Springs, NC

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

  • 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

Job Summary:

The Senior CQV Engineer is responsible for leading and executing Commissioning, Qualification, and Validation (CQV) activities with a strong focus on CIP (Clean-In-Place) systems supporting Drug Substance Manufacturing. This role will serve as a technical subject matter expert for CIP system qualification and cleaning validation, ensuring compliance with GMP, regulatory, and internal quality standards.

The ideal candidate brings hands-on experience in CIP system design review, qualification execution, and cleaning validation strategy, and can work independently in a fast-paced manufacturing environment while collaborating cross-functionally with Engineering, Manufacturing, Quality, and Automation teams.

Senior CQV Engineer Responsibilities:

CQV & Validation Execution

  • Lead and execute commissioning, qualification, and validation activities for CIP systems supporting Drug Substance manufacturing operations
  • Author, review, and execute IQ, OQ, and PQ protocols for CIP equipment and associated utilities
  • Perform cleaning validation activities for CIP systems, including development of validation strategies, protocols, sampling plans, and final reports
  • Ensure CIP systems meet regulatory expectations for cleanability, reproducibility, and worst-case conditions

CIP & Cleaning Validation

  • Act as the SME for CIP systems, including spray devices, flow paths, cycle development, and acceptance criteria
  • Support CIP cycle development and optimization in collaboration with Engineering and Manufacturing
  • Perform risk assessments (e.g., FMEA, HACCP) to define validation scope and acceptance criteria
  • Support residue, bioburden, and TOC sampling strategies as part of cleaning validation

Drug Substance Manufacturing Support

  • Support Drug Substance manufacturing equipment and processes, ensuring validation activities align with process requirements and regulatory expectations
  • Collaborate with Process Engineering and Manufacturing to ensure validated cleaning processes support operational efficiency and compliance
  • Provide validation support during tech transfers, process changes, and new equipment installations

Compliance & Documentation

  • Ensure all CQV and cleaning validation documentation complies with GMP, FDA, EMA, and ICH requirements
  • Participate in deviation investigations, CAPAs, and change controls related to CIP systems and cleaning validation
  • Support internal and external audits and regulatory inspections

Cross-Functional Collaboration

  • Work closely with Engineering, Automation, Manufacturing, Quality Assurance, and Validation teams
  • Provide guidance and mentoring to junior CQV engineers and validation resources as needed

Requirements:

  • Bachelor’s degree in Engineering, Chemistry, Biology, or a related technical discipline (or equivalent experience)
  • 6+ years of hands-on experience in CQV / Validation within a GMP manufacturing environment
  • Strong experience with CIP systems, including:
    • CIP system qualification (IQ/OQ/PQ)
    • Cleaning Validation in CIP
    • CIP cycle development and optimization
  • Demonstrated experience supporting Drug Substance Manufacturing operations
  • Deep understanding of CIP system design, qualification, and validation
  • Strong knowledge of cleaning validation principles and regulatory expectations
  • Experience with GMP documentation and validation lifecycle
  • Ability to work independently and lead validation activities
  • Strong technical writing and communication skills
  • Detail-oriented with strong problem-solving abilities
  • Experience with automated CIP systems and process control
  • Familiarity with biopharmaceutical or biotech manufacturing environments
  • Experience supporting regulatory inspections (FDA, EMA)
  • Prior experience mentoring or leading validation efforts
  • Onsite presence in manufacturing and cleanroom environments
  • Onsite presence required in Holly Springs, 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

$70,491 - $118,062 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

Verista collects and processes personal data in accordance with applicable data protection laws.  If you are a California Job Applicant, see the privacy notice for further details. 

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

Create a Job Alert

Interested in building your career at Verista, Inc.? Get future opportunities sent straight to your email.

Apply for this job

*

indicates a required field

Resume/CV*

Accepted file types: pdf, doc, docx, txt, rtf

Education

Select...
Select...
Select...

Current residential street address (e.g. 1600 Pennsylvania Ave NW)

Please enter the city where you currently reside.

Select...

State in which you currently reside.

What are your specific areas of expertise?

Select...

Enter number of years of experience within the Life Sciences Industry, regardless of role.

Enter your number of years of role specific experience.

List any certifications your hold?

Select...
Select...

Traveling to support client needs are an expectation of Verista Resources.  Are you open to at least 50% travel?

Select...

Can you meet the travel and on-site requirements defined for this role?

Select...

Sponsorship question

Select...

U.S. Standard Demographic Questions

We invite applicants to share their demographic background. If you choose to complete this survey, your responses may be used to identify areas of improvement in our hiring process.
Select...
Select...
Select...
Select...
Select...
Select...

Voluntary Self-Identification

For government reporting purposes, we ask candidates to respond to the below self-identification survey. Completion of the form is entirely voluntary. Whatever your decision, it will not be considered in the hiring process or thereafter. Any information that you do provide will be recorded and maintained in a confidential file.

As set forth in Verista, Inc.’s Equal Employment Opportunity policy, we do not discriminate on the basis of any protected group status under any applicable law.

Select...
Select...
Race & Ethnicity Definitions

If you believe you belong to any of the categories of protected veterans listed below, please indicate by making the appropriate selection. As a government contractor subject to the Vietnam Era Veterans Readjustment Assistance Act (VEVRAA), we request this information in order to measure the effectiveness of the outreach and positive recruitment efforts we undertake pursuant to VEVRAA. Classification of protected categories is as follows:

A "disabled veteran" is one of the following: a veteran of the U.S. military, ground, naval or air service who is entitled to compensation (or who but for the receipt of military retired pay would be entitled to compensation) under laws administered by the Secretary of Veterans Affairs; or a person who was discharged or released from active duty because of a service-connected disability.

A "recently separated veteran" means any veteran during the three-year period beginning on the date of such veteran's discharge or release from active duty in the U.S. military, ground, naval, or air service.

An "active duty wartime or campaign badge veteran" means a veteran who served on active duty in the U.S. military, ground, naval or air service during a war, or in a campaign or expedition for which a campaign badge has been authorized under the laws administered by the Department of Defense.

An "Armed forces service medal veteran" means a veteran who, while serving on active duty in the U.S. military, ground, naval or air service, participated in a United States military operation for which an Armed Forces service medal was awarded pursuant to Executive Order 12985.

Select...

Voluntary Self-Identification of Disability

Form CC-305
Page 1 of 1
OMB Control Number 1250-0005
Expires 04/30/2026

Why are you being asked to complete this form?

We are a federal contractor or subcontractor. The law requires us to provide equal employment opportunity to qualified people with disabilities. We have a goal of having at least 7% of our workers as people with disabilities. The law says we must measure our progress towards this goal. To do this, we must ask applicants and employees if they have a disability or have ever had one. People can become disabled, so we need to ask this question at least every five years.

Completing this form is voluntary, and we hope that you will choose to do so. Your answer is confidential. No one who makes hiring decisions will see it. Your decision to complete the form and your answer will not harm you in any way. If you want to learn more about the law or this form, visit the U.S. Department of Labor’s Office of Federal Contract Compliance Programs (OFCCP) website at www.dol.gov/ofccp.

How do you know if you have a disability?

A disability is a condition that substantially limits one or more of your “major life activities.” If you have or have ever had such a condition, you are a person with a disability. Disabilities include, but are not limited to:

  • Alcohol or other substance use disorder (not currently using drugs illegally)
  • Autoimmune disorder, for example, lupus, fibromyalgia, rheumatoid arthritis, HIV/AIDS
  • Blind or low vision
  • Cancer (past or present)
  • Cardiovascular or heart disease
  • Celiac disease
  • Cerebral palsy
  • Deaf or serious difficulty hearing
  • Diabetes
  • Disfigurement, for example, disfigurement caused by burns, wounds, accidents, or congenital disorders
  • Epilepsy or other seizure disorder
  • Gastrointestinal disorders, for example, Crohn's Disease, irritable bowel syndrome
  • Intellectual or developmental disability
  • Mental health conditions, for example, depression, bipolar disorder, anxiety disorder, schizophrenia, PTSD
  • Missing limbs or partially missing limbs
  • Mobility impairment, benefiting from the use of a wheelchair, scooter, walker, leg brace(s) and/or other supports
  • Nervous system condition, for example, migraine headaches, Parkinson’s disease, multiple sclerosis (MS)
  • Neurodivergence, for example, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, dyslexia, dyspraxia, other learning disabilities
  • Partial or complete paralysis (any cause)
  • Pulmonary or respiratory conditions, for example, tuberculosis, asthma, emphysema
  • Short stature (dwarfism)
  • Traumatic brain injury
Select...

PUBLIC BURDEN STATEMENT: According to the Paperwork Reduction Act of 1995 no persons are required to respond to a collection of information unless such collection displays a valid OMB control number. This survey should take about 5 minutes to complete.