Computer Systems Validation Specialist
Lonza · Portsmouth, NH · Yesterday
Information TechnologyFull-time
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.
- Access to our full list of global benefits: here.
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 DeltaV 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.
- 3+ years experience in Computer Systems Validation and in a cGMP facility.
- 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, DeltaV 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.