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
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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, ensuring computer systems meet regulatory compliance standards.

The position offers an opportunity to work with one of the most recognizable brands in the life science industry, focusing on solving pressing healthcare challenges. The ideal candidate will have extensive experience in Computer System Validation within GMP-regulated environments, preferably in pharmaceuticals or biotechnology.

As a Senior CSV Engineer, you'll be responsible for developing and executing validation protocols, collaborating with automation teams, managing documentation lifecycles, and ensuring regulatory compliance. The role requires strong technical expertise combined with excellent communication skills to effectively interact with various stakeholders.

The company culture emphasizes empowerment, client success, and continuous learning. 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 position is based in Warren, NJ, with some possibility for remote work with approval.

This role is perfect for someone who thrives in a fast-paced environment, has a strong technical background, and is passionate about making an impact in the healthcare industry. The position offers growth opportunities within a rapidly expanding organization that values its employees and maintains a people-focused culture.

Last updated 4 months 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 client site in 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
  • Tuition Reimbursement
  • Paid Parental Leave
  • Team Social Activities

Interested in this job?