CSV Specialist Level 3 ? Portsmouth, NH
This is an office-first role based on site in Portsmouth, NH. Working together in person supports close, real-time collaboration and team alignment, enabling us to deliver our best work. You will work primarily in the office, with the flexibility to work remotely for 20% of your time (one day per week).
What you will get:
Compensation for this role will be determined by the candidate?s qualifications, skills, experience, and relevant knowledge.
What you will do:
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.
Maintain the ongoing validation state of computerized systems through routine validation maintenance and periodic system reviews.
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.
What we are looking for:
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.
Strong technical expertise with DeltaV (DCS) and Syncade (MES) automation systems.
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.
About Lonza
At Lonza, their people are their greatest strength. With 30+ sites across five continents, their globally connected teams work together every day to manufacture the medicines of tomorrow. Their core values of Collaboration, Accountability, Excellence, Passion and Integrity reflect who they are and how they work together. Everyone?s ideas, big or small, have the potential to improve millions of lives, and that?s the kind of work they want you to be part of.
Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, they value diversity and are committed to creating an inclusive environment.
As Lonza?s talent acquisition partner, please note, Randstad is responsible for the engagement and contracting of this contingent role.
Ready to play your part in shaping the future of life sciences? Apply now.
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