Lead Engineer - Analytical Equipment Validation

Lonza•Portsmouth, NH

About The Position

Lead Engineer - Analytical Equipment Validation Location: Portsmouth, NH. Relocation assistance is available for eligible candidates and their families, if needed. The focus of the Computer Systems Validation (CSV)Lead Engineer role is to identify or create industry best practices and implement these within the framework of existing GAMP regulations. Responsibilities of the CSV Lead Engineer will include risk assessing systems, reviewing change requests and test scripts, drafting protocols and initiating and reviewing GMP documentation revisions as well as ownership of department procedures. The position provides guidance to junior team members. What you will get An agile career and dynamic working culture. An inclusive and ethical workplace. Compensation programs that recognize high performance. Medical, dental and vision insurance. Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits .

Requirements

Bachelor’s Degree is required (preferably in Computer Science/Software Engineering)
5-10 years’ of Computer Systems Validation experience
Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation
Strong written and oral communication skills
Strong organizational and time management skills

Responsibilities

Lead collaboration between internal teams and CSV to prioritize and complete activities on time
Maintain knowledge of Lonza policies, 21 CFR Part 11, Data Integrity, ICH Q7A, and GAMP principles
Perform QMS processes (Change Control, Deviation, CAPA) and validation maintenance of computerized systems
Participate in audits and inspections as a Subject Matter Expert
Own, revise and maintain CSV SOPs
Support qualification activities and documentation for CSV validation in line with regulatory guidelines
Mentor and train junior team members