Computer Systems Validation Specialist, Level 2

Lonza•Portsmouth, NH

23h•Onsite

About The Position

The Computer Systems Validation (CSV) Specialist, Level 2 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. At Lonza, our people are our greatest strength. With 30+ sites across five continents, our globally connected teams work together every day to manufacture the medicines of tomorrow. Our core values—Collaboration, Accountability, Excellence, Passion, and Integrity—reflect who we are and how we work together. Everyone’s ideas, big or small, have the potential to improve millions of lives, and that’s the kind of work we want you to be part of. Innovation thrives when people from all backgrounds bring their unique perspectives to the table. At Lonza, we offer equal employment opportunities to all qualified applicants regardless of race, religion, color, national origin, sex, sexual orientation, gender identity, age, disability, veteran status, or any other characteristic protected by law. If you’re ready to help turn our customers’ breakthrough ideas into viable therapies, we look forward to welcoming you on board.

Requirements

Bachelor’s degree in computer science, engineering, or related field
0-4 years experience in Computer Systems 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
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

Nice To Haves

DeltaV is preferred

Responsibilities

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