A Validation Specialist tests and documents the validity and accuracy of manufacturing systems and equipment. Tests processes and manages process validations. Provides technical support and implements operating procedures. May create documentation to show that a manufacturing or production process has consistent results and meets quality standards.
Portsmouth, NH. Relocation assistance is available for eligible candidates and their families. The Computer Systems Validation (CSV) Specialist 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. Access to our full list of global benefits: https://www.lonza.
com/careers/benefits 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.
About Lonza:
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. Ready to shape the future of life sciences? .
