CSA/CSV Validation Lead

Trissential is seeking a CSA/CSV Validation Lead to join our client team remotely in Minneapolis, MN. In this role, you’ll apply your expertise in instrument validation, technical writing, and documentation to ensure that critical systems meet the highest quality and regulatory standards. Your work will play a pivotal role in maintaining compliance, improving efficiency, and driving innovation in a dynamic and collaborative environment. This is an opportunity to bring your technical skills, problem-solving abilities, and consultative mindset to a team where your impact truly matters. Please note: This role is open only to candidates authorized to work in the US. If you’re ready to make your mark in this key role, we’d love to hear from you!

Responsibilities

• Lead efforts in instrument validation and computer system validation (CSV) to meet regulatory and quality standards
• Develop, execute, and manage system risk assessments, test scripts, and technical documentation
• Conduct system test script development, user acceptance testing, and system test execution in accordance with CSV methodologies
• Collaborate with cross-functional teams to ensure compliance with validation requirements
• Deliver technical writing and documentation that meet high-quality standards
  
  

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, or a related field, or equivalent work experience
• Certification or coursework in Quality Assurance or Validation is highly desirable
  
  

Essential Skills

• Proficiency in instrument validation and computer system validation processes, with a deep understanding of technical writing and documentation
• Strong ability to conduct system risk assessments and execute validation test scripts
• A collaborative and consultative mindset with the ability to work independently or within a team
• Eagerness to grow your knowledge base and adapt in a fast-paced, evolving environment
• Strong attention to detail and a commitment to delivering high-quality outcomes
  
  

Desired Skills

• Familiarity with GAMP5 methodologies and Agile practices is a plus
• Experience in regulated or life sciences environments with a solid understanding of compliance requirements
  
  

Experience

• Minimum of 5 years of experience in validation or a related role within a regulated or life sciences environment
• Proven expertise in instrument validation, CSV, and technical documentation
  
  

Benefits

Trissential offers a competitive compensation package for full time roles. The hourly pay range for this role is $54 to $64 depending on candidate's qualifications and experience. This role is eligible for benefits and includes options for medical, dental, vision, and tele-health benefits; Health Savings Account with company contribution; up to 48 hours of accrued paid safe and sick time, and 401k retirement savings.