CQV Specialist / Senior Validation Engineer 2 - 5380

A team of 600 experts partnering with life science industry brands to solve business needs and healthcare challenges.
Warren, NJ, USA
$80,465 - $116,843
Backend
Senior Software Engineer
In-Person
501 - 1,000 Employees
5+ years of experience
Healthcare

Description For CQV Specialist / Senior Validation Engineer 2 - 5380

Verista, a prominent player in the life sciences industry with a 600-strong expert team, is seeking a Senior CQV Engineer to join their dynamic organization. This role offers an exciting opportunity to work with world-class professionals in a regulated environment, focusing on commissioning and qualification activities for critical systems.

The position involves developing and executing comprehensive validation documentation for bulk CO2 gas systems, ensuring compliance with cGMP standards, and maintaining high-quality documentation throughout project lifecycles. You'll be working in Warren, NJ, collaborating with cross-functional teams to ensure successful system implementations.

As a Senior CQV Engineer, you'll be responsible for coordinating gas sampling activities, addressing technical challenges, and making impactful recommendations for process improvements. The role requires strong expertise in document authorship and a deep understanding of validation guidelines and quality management systems.

The company offers an attractive compensation package ranging from $80,465 to $116,843, along with comprehensive benefits including medical, dental, and vision insurance, 401(k) with employer matching, and various other perks. Verista's culture emphasizes employee growth, innovation, and work-life balance, making it an ideal environment for professionals looking to advance their careers in the life sciences industry.

The ideal candidate will have 5+ years of relevant experience, strong communication skills, and a proven track record in GMP environments. This role presents an excellent opportunity to join a growing organization that values its employees and maintains a strong focus on client success and innovation in healthcare solutions.

Last updated 5 days ago

Responsibilities For CQV Specialist / Senior Validation Engineer 2 - 5380

  • Develop, author, and execute commissioning and qualification (CQV) documentation for the Bulk CO2 Gas System
  • Collaborate with project teams for system installation, commissioning, and validation
  • Coordinate and document gas sampling activities
  • Prepare and deliver high-quality documentation aligned with cGMP standards
  • Identify and address technical challenges during commissioning and qualification
  • Maintain documentation quality and accuracy
  • Author, edit, and execute technical commissioning documentation
  • Run test scripts and document results
  • Develop, review, and execute testing documentation
  • Make recommendations for design or process modification

Requirements For CQV Specialist / Senior Validation Engineer 2 - 5380

  • Bachelor's Degree or equivalent required
  • 5+ years of experience in CQV activities in regulated environment
  • Strong expertise in document authorship
  • Hands-on experience with gas sampling coordination
  • Knowledge of cGMP regulations
  • Exceptional organizational and communication skills
  • Proficiency in Microsoft Office tools
  • Experience in GMP regulated environment
  • Strong attention to detail
  • Must be willing to work onsite in Warren, NJ

Benefits For CQV Specialist / Senior Validation Engineer 2 - 5380

Medical Insurance
Dental Insurance
Vision Insurance
401k
Commuter Benefits
Parental Leave
  • Competitive pay plus performance-based incentives
  • Company-paid Life, Short-Term, and Long-Term Disability Insurance
  • Medical, Dental & Vision insurances
  • FSA, DCARE, Commuter Benefits
  • Health Savings Account
  • 401(k) Retirement Plan with Employer Matching
  • Paid Time Off with Rollover Option
  • Tuition Reimbursement
  • Paid Parental Leave and Bereavement
  • Employee Recognition Program

Interested in this job?

Jobs Related To Verista CQV Specialist / Senior Validation Engineer 2 - 5380

CQV Specialist / Senior Validation Engineer

Senior CQV Engineer position at Verista, focusing on gas system validation and qualification, offering competitive salary and benefits in Warren, NJ.

Senior Process Engineer / Senior Process Engineer 2 - 5350

Senior Process Engineer position at Verista focusing on biological process validation and qualification in the life sciences industry.

Senior CQV Engineer / Lead Validation Engineer

Senior CQV Engineer position at Verista, leading validation projects in GMP environments with competitive benefits and salary range $87,780-$134,153.

Senior Process Engineer / Senior Process Engineer 2 - 5350

Senior Process Engineer position at Verista offering remote work with 50% travel requirement based in the West Region.

Senior CSV Engineer/Analyst - Senior Validation Engineer

Senior CSV Engineer position at Verista, focusing on computer system validation for cell therapy manufacturing, offering competitive benefits and growth opportunities in Warren, NJ.