Validation Engineering

CSV Specialist Level 3 – Portsmouth, NH This is an office-first role based on site in Portsmouth, NH. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).
An agile career and dynamic working culture.
Competitive hourly rate.
Lead risk assessments, change requests, test scripts, and validation protocols for new and existing computerized systems to ensure compliance with company policies and regulatory guidelines.
Oversee and perform all Computer Systems Validation (CSV) qualification activities for automated systems, including DeltaV and Syncade.
Manage and execute all Quality Management System (QMS) processes, including Change Controls, Deviations, CAPAs, and system risk assessments.
Act as the Quality Assurance CSV project lead on small- to large-scale site capital and operational projects.
Review and revise CSV Standard Operating Procedures (SOPs) and engineering documents, including P&IDs, specifications, and submittals.
Provide technical guidance, leadership, and mentorship to junior CSV team members while assisting with regulatory audits and inspections.
Bachelor’s Degree in Computer Science, Software Engineering, or a related STEM field required.

• 5–10 years of advanced experience in Computer Systems Validation (CSV) within a cGMP regulated biopharmaceutical environment.
• Deep understanding of 21 CFR Part 11, Annex 11, and ISPE GAMP5 guidelines as applied to software and automated manufacturing systems.
• Proven experience executing QMS lifecycle processes (Deviations, CAPAs, Change Controls) and supporting regulatory audits.
• Excellent project leadership, organizational, and cross-functional communication skills.

With 30+ sites across five continents, their globally connected teams work together every day to manufacture the medicines of tomorrow. At Lonza, they value diversity and are committed to creating an inclusive environment.