Lonza
Equipment Validation Specialist, Level III
US - Portsmouth, NH · Mid
Sponsorship not specifiedDetected 5 days ago
VoIPGMPLeadershipCollaborationTime ManagementWriting
About the role
- Equipment Validation Specialist, Level III Location: On-site, Portsmouth, NH.
- Relocation assistance is available for eligible candidates and their families.
- About Lonza At Lonza, our people are our greatest strength.
Responsibilities
- Perform Equipment Validation Maintenance Quality Systems review and re-qualification activities to ensure GMP equipment is continuously maintained in a validated state.
- Schedule own tasks to be performed as well as tasks for Level 1 and Level 2 Specialist as determined by the Validation Manager.
- Program, organize, and maintain Validation equipment and supplies and train new personnel in these areas.
- and Equipment. Develop validation protocols from Validation plans and engineering documents.
- Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements.
- Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control).
- Strong technical writing skills and ability to document all work in a meticulous, accurate, and timely manner.
- Understand how to write discrepancies, give a root cause analysis and perform Quality Risk Assessments.
- Demonstrates ability to prioritize tasks as needed to support the changing business demands.
- This role provides Operations, Quality Assurance, clients, and regulatory bodies with scientifically sound, documented evidence that systems and processes perform reliably to maintain a compliant manufacturing environment.
Requirements
- At least 2+ years of experience working with Manufacturing processes, QC or Environmental Monitoring.
- Experience with Quality Systems including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control).
Nice to have
- Bachelor's degree is preferred or equivalent industry experience.
Skills
- A collaborative and inclusive work environment.
- Opportunities for career growth and development.
- Access to cutting-edge technologies and tools.
- Competitive compensation and benefits package.
- 401(k) matching plan.
- Supportive leadership and mentoring.
- Commitment to ethical and sustainable practices.
Compensation
- Competitive compensation and benefits package.
Benefits
- https://www.lonza.com/careers/benefits
Company info
- What we are looking for:
- 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.
- If you're ready to help turn our customers' breakthrough ideas into viable therapies, we look forward to welcoming you on board.
This listing is sourced directly from Lonza's careers page and normalized into a canonical job model.