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Principal CQV Engineer / Lead Validation Engineer

Verista, Inc.Holly Springs, NC
On-site Full-time $87.8K/yr - $136.2K/yr

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Experience Level

Mid to Senior

Qualifications

Qualifications and Requirements:Proven experience in upstream bioprocessing systems. Strong understanding of the CQV lifecycle. Ability to author comprehensive validation documentation. Experience in coordinating commissioning activities. Familiarity with vendor testing processes. Knowledge of cGMP and regulatory requirements. Experience with digital validation platforms is a plus.

About the job

Position Overview

Verista’s dedicated team of over 500 professionals collaborates with some of the most prominent brands in the life sciences sector, addressing their business challenges. We are committed to fostering growth and innovation within the scientific community, assisting researchers, organizations, and companies in tackling critical healthcare issues. Our innovative solutions and services facilitate informed decision-making, stemming from our substantial investment in our workforce and capabilities.

Our growth is propelled by exceptional individuals who excel in collaborative environments and align with our mission to empower life sciences clients to enhance lives. Our talented and devoted professionals strive to make a meaningful impact every day.

Company Culture and Values:

  • We empower and support our colleagues.
  • We are committed to client success at every opportunity.
  • We possess the courage to make ethical decisions.
  • We foster an inclusive environment where colleagues feel valued, engaged, and challenged.
  • We continuously seek to acquire new skills and learn from our experiences to enrich our collective knowledge.

We are currently in search of a CQV Engineer with hands-on experience in upstream bioprocessing systems to facilitate commissioning, qualification, and validation activities for biopharmaceutical manufacturing operations. This role will concentrate on upstream unit operations and process equipment, ensuring that systems are designed, installed, tested, and qualified in compliance with cGMP and regulatory standards.

The ideal candidate will possess robust experience throughout the CQV lifecycle, including the preparation of validation documentation, coordination of commissioning activities, support for vendor testing, and assurance that systems meet operational readiness criteria. Familiarity with digital validation platforms like Kneat is highly advantageous.

This position necessitates a self-starter who can work independently while also engaging collaboratively within teams.

About Verista, Inc.

Verista, Inc. partners with leading life science organizations to provide expert solutions that drive innovation and success in the industry. Our commitment to employee development ensures we are equipped to meet the evolving challenges of the healthcare landscape.

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