Lonza
Equipment Validation Specialist, Level III
United States · Work style not stated · Full time
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About the role
Description from the employer’s posting. Check the employer’s page for the current version.
- EmployerLonza
- LocationUnited States
- Work styleWork style not stated
- Employment typeFull time
- Employer posted
Equipment Validation Specialist, Level III
Location: On-site, Portsmouth, NH. Relocation assistance is available for eligible candidates and their families.
The Equipment Validation Specialist 3 ensures all critical GMP equipment and systems are validated and maintained in compliance with user requirements, process parameters, and global regulatory guidelines. 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.
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.
401(k) matching plan.
Supportive leadership and mentoring.
Show full description
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 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.
Perform change control assessments for GMP equipment and associated validation activities to ensure compliance with regulatory requirements.
Program, organize, and maintain Validation equipment and supplies and train new personnel in these areas.
Demonstrate a thorough understanding of biopharmaceutical manufacturing equipment and validation procedures for Installation Qualification (IQ), Steam-In-Place (SIP), Autoclaves, Clean Utilities, Shipping Validation, Temperature Mapping Controlled Storage Rooms.
and Equipment. Develop validation protocols from Validation plans and engineering documents.
Provide strong technical expertise when reviewing and approving SOPs, protocols, change controls, deviations.
Perform assigned Quality Systems activities including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control).
What we are looking for:
Bachelor’s degree is preferred or equivalent industry experience.
At least 2+ years of experience working with Manufacturing processes, QC or Environmental Monitoring.
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.
Experience with Quality Systems including: Document Management System (DMS), Laboratory Information Management System (LIMS) and Trackwise system (Change Control).
Demonstrates ability to prioritize tasks as needed to support the changing business demands.
Ability to work independently and on-site in Portsmouth NH with strong organizational and time management skills.
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? Apply now.
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At a glance
- Employment typeFull time
- Employer posted
- Added to ROLIVA
- Last checked