Equipment Validation Specialist, Level III

Lonza • Portsmouth, NH

7d • Onsite

About The Position

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.

Requirements

• 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.

Nice To Haves

• Bachelor’s degree is preferred or equivalent industry experience.

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.
• 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).

Benefits

• 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.
• Access to our full list of global benefits: https://www.lonza.com/careers/benefits
• Relocation assistance is available for eligible candidates and their families.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Associate degree