Senior CSV Engineer/Analyst - Senior Validation Engineer

A team of 600 experts partnering with life science industry brands to solve business needs and healthcare challenges.
Warren, NJ, USA
$70,491 - $115,000
Backend
Senior Software Engineer
In-Person
501 - 1,000 Employees
5+ years of experience
Healthcare · Biotech

Description For Senior CSV Engineer/Analyst - Senior Validation Engineer

Verista, a leading life sciences solutions provider with 600 experts, is seeking a Senior CSV Engineer/Analyst to join their team in Warren, NJ. This role is crucial for supporting commissioning and qualification efforts in cell therapy manufacturing projects. The position focuses on ensuring computer systems meet regulatory compliance standards and are properly validated for product manufacturing.

The ideal candidate will bring 5+ years of experience in Computer System Validation within GMP-regulated environments, preferably in pharmaceuticals or biotechnology. You'll be responsible for developing and executing validation protocols, managing documentation lifecycles, and ensuring regulatory compliance. This role offers an opportunity to work with cutting-edge cell therapy manufacturing processes while maintaining strict quality standards.

Verista offers a comprehensive benefits package including competitive salary ($70,491-$115,000), medical/dental/vision insurance, 401(k) with employer matching, and various other perks. The company culture emphasizes empowerment, client success, and continuous learning, making it an ideal environment for professional growth.

The position requires strong technical expertise combined with excellent communication skills, as you'll be collaborating with various teams and stakeholders. While primarily on-site in Warren, NJ, there may be some flexibility for remote work with approval. This role is perfect for someone who wants to make a meaningful impact in the life sciences industry while working with a company that values innovation and professional development.

Last updated a month ago

Responsibilities For Senior CSV Engineer/Analyst - Senior Validation Engineer

  • Develop and execute CSV protocols, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), for manufacturing equipment
  • Collaborate with automation and validation teams to ensure systems meet project and regulatory compliance standards
  • Manage document lifecycle, including creation, revision, and storage
  • Participate in weekly project meetings
  • Conduct risk assessments and generate compliance reports
  • Oversee vendor interactions and track vendor deliverables

Requirements For Senior CSV Engineer/Analyst - Senior Validation Engineer

  • Bachelor's degree in Engineering, Computer Science, or Life Sciences
  • Minimum 5 years of experience in Computer System Validation in GMP-regulated environment
  • Strong knowledge of regulatory compliance requirements
  • Experience with DeltaV control systems
  • Excellent organizational, communication, and documentation skills
  • Advanced Microsoft WORD, EXCEL, and PowerPoint capabilities
  • Must be available to work onsite at Warren, NJ

Benefits For Senior CSV Engineer/Analyst - Senior Validation Engineer

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
  • Paid Holidays
  • Tuition Reimbursement
  • Paid Parental Leave
  • Employee Recognition Program
  • Employee Referral Program

Interested in this job?

Jobs Related To Verista Senior CSV Engineer/Analyst - Senior Validation Engineer

Senior Program Manager - Lead Validation Engineer

Senior Program Manager position leading validation engineering and SDMS implementation for life sciences company Verista, offering competitive benefits and growth opportunities.

CQV Specialist / Senior Validation Engineer 2 - 5380

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

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.