Computer Systems Validation Specialist, Level 3

United States, Portsmouth (New Hampshire)

Lonza is a global leader in life sciences operating across five continents. While we work in science, there’s no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world.

And that’s the kind of work we want to be part of.

Job Summary

The Computer Systems Validation (CSV) Specialist, Level 3 helps to lead team members to assess new and changing computer systems to ensure compliance with company policies, procedures and industry guidance. The CSV Specialist will risk assess systems, review change requests and test scripts, draft protocols and initiate and review GMP documentation revisions. This position also provides guidance to junior team members and will be involved as the QA CSV representative during small and large-scale projects.

What You Will Get

• A collaborative and inclusive work environment
• Opportunities for career growth and development
• Access to cutting-edge technologies and tools
• Competitive compensation and benefits package
• Supportive leadership and mentoring
• Commitment to ethical and sustainable practices
• Relocation support if required

What You Will Do

• Perform all aspects of QMS process’ – Change Control, Deviations, CAPAs
• Execute all responsibilities as CSV project lead for simple projects
• Oversee/perform all CSV qualification activities for Delta
  
  V and Syncade systems
• Perform Validation Maintenance of computerized systems
• Review/Revise CSV SOPs
• Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.)
• Assist with audits and inspections

What We Are Looking For

• Bachelor’s degree in computer science, engineering, or related field
• At least 2 years of experience in automation or system validation
• 1+ years with Programmable Logic Controllers (PLC), Controls Automation, Process Control Systems, SCADA Systems, Distributed Controls Systems (DCS), Building Alarm Systems (BAS), Building Management Systems (BMS), Manufacturing Execution Systems (MES) required, Delta
  
  V is preferred
• Experience leading projects and managing CAPAs and deviations
• Background in biotech, pharma, or medical device industry
• Strong attention to detail and ability to meet deadlines
• Ability to work independently and on-site in Portsmouth NH

Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Reference: R71059

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