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6242 - Upstream Principal CQV Engineer / Lead 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

We are seeking a CQV Engineer with hands-on experience in upstream bioprocessing systems to support commissioning, qualification, and validation activities for biopharmaceutical manufacturing operations. This role will focus on upstream unit operations and process equipment, ensuring systems are designed, installed, tested, and qualified in accordance with cGMP and regulatory expectations.

The ideal candidate will bring strong experience across the CQV lifecycle, including authoring validation documentation, coordinating commissioning activities, supporting vendor testing, and ensuring systems achieve operational readiness. Experience with digital validation platforms such as Kneat is highly desirable.

This position requires someone who can work independently while collaborating cross-functionally with engineering, automation, vendors, and quality teams to ensure successful project execution.

 

Upstream Principal CQV Engineer Responsibilities:

Commissioning, Qualification & Validation

  • Support commissioning, qualification, and validation (CQV) activities for upstream bioprocess equipment and systems.

  • Author, review, and execute CQV lifecycle documentation including:

    • Commissioning test protocols

    • Installation Qualification (IQ)

    • Operational Qualification (OQ)

    • Performance Qualification (PQ)

    • Validation summary reports

  • Ensure validation documentation aligns with cGMP requirements and regulatory expectations.

  • Participate in system impact assessments, risk assessments, and validation planning activities.

Upstream Bioprocess Support

  • Provide technical support for upstream bioprocess unit operations, including systems such as:

    • Bioreactors / fermenters

    • Media and buffer preparation systems

    • Cell culture support equipment

    • Filtration and associated upstream utilities

  • Support equipment startup and operational readiness for upstream process systems.

  • Collaborate with engineering and operations teams to resolve technical issues during commissioning and qualification.

Vendor & Startup Activities

  • Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT) for new equipment.

  • Coordinate with equipment vendors and integrators to ensure proper system installation and functionality.

  • Participate in equipment startup, troubleshooting, and performance verification.

Cross-Functional Coordination

  • Work closely with engineering, automation, quality assurance, and manufacturing teams to align project deliverables.

  • Ensure commissioning and validation activities remain aligned with project timelines and milestones.

  • Assist with deviation resolution, change control, and documentation updates as required.

Digital Validation Systems

  • Utilize electronic validation platforms (e.g., Kneat) to develop and execute validation documentation.

  • Ensure documentation integrity, traceability, and compliance within digital validation systems

 

Requirements:

  • Bachelor’s degree in Engineering, Life Sciences, Biotechnology, or related technical field

  • Experience supporting CQV activities within GMP-regulated pharmaceutical or biotechnology environments

  • Hands-on experience with upstream bioprocess equipment and systems

  • Strong understanding of CQV lifecycle documentation (IQ/OQ/PQ, protocols, reports)

  • Ability to work cross-functionally with engineering, automation, vendors, and quality teams

  • Strong communication, documentation, and organizational skills

  • Experience with digital validation platforms such as Kneat

  • Experience supporting FAT/SAT, commissioning, and equipment startup

  • Familiarity with risk-based validation approaches

  • Prior experience in biologics or cell culture manufacturing environments

  • Onsite job requirement 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

$87,780 - $136,225 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

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