Equipment Validation Specialist, Level III

Lonza; Portsmouth (NH); Presencial; Confidential; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Collaborative work environment

Career growth

Access to cutting-edge technologies

Competitive compensation

401(k) matching

Mentoring and leadership

Descripción de la vacante

Lonza in Portsmouth, NH seeks an Equipment Validation Specialist, Level III to ensure GMP equipment and systems are validated and maintained in alignment with user requirements and regulatory guidelines.

You will perform maintenance, change controls, IQ/SIP, and QA support, while training new personnel and collaborating with Operations, QA and regulatory bodies.

Relocation assistance is available; this role emphasizes meticulous documentation, technical writing, and on-site work in Portsmouth NH.

Formación

• Bachelor's degree preferred or equivalent industry experience.
• 2+ years in Manufacturing, QC or Environmental Monitoring.
• Strong technical writing and meticulous documentation.
• Experience with QMS including DMS, LIMS and TrackWise.
• Ability to perform root cause analysis and risk assessments.
• Ability to prioritize tasks and work on-site in Portsmouth NH.

Responsabilidades

• Perform 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).

Conocimientos

Technical writing

Quality systems

Documentation

Root cause analysis

Priority management

Independence

Educación

Bachelor's degree or equivalent

2+ years GMP/Manufacturing experience

Herramientas

DMS

LIMS

Trackwise

Descripción del empleo

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.

• Commitment to ethical and sustainable practices.

Access to our full list of global benefits: 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.