Lonza

LeadEngineerAnalyticalEquipmentValidation

Portsmouth, New Hampshire, United States FULL TIME
The Brief

“Lead Engineer - Analytical Equipment Validation at Lonza. Skills: Computer Systems Validation, GAMP principles, 21 CFR Part 11. Risk assess systems. Review change requests”

Industry & Context.

Eligibility Requirements

Relocation assistance is available

What They're Looking For.

Must Have

Bachelor's Degree, 5-10 years’ of Computer Systems Validation experience, Experience with 21 CFR Part 11, Experience with ISPE GAMP guidelines, written and oral communication skills, organizational and time management skills

Nice to Have

Computer Science/Software Engineering degree

What You'll Do.

Review change requests

Initiate GMP documentation revisions

Perform QMS processes

Maintain computerized systems

Support qualification activities

Support documentation

Mentor junior team members

Train junior team members

How You'll Work.

Team & Collaboration

Lead collaboration between internal teams; Work with CSV

Communication Scope

written and oral communication skills

Free ATS check

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