Bachelor’s Degree in Computer Science/Software Engineering or related field
5-10 years of experience in Computer Systems Validation
Familiarity with 21 CFR Part 11 and ISPE GAMP guidelines
Strong written and oral communication skills
Excellent organizational and time management skills
Responsibilities
Lead collaboration between internal teams and CSV for timely activity completion
Maintain up-to-date knowledge of relevant regulations and policies
Perform QMS processes including Change Control, Deviation, and CAPA
Participate in audits and inspections as a Subject Matter Expert
Own and maintain CSV SOPs
Support CSV validation qualification activities and documentation
Function as CSV SME during inspections and audits
Benefits
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
Commitment to ethical and sustainable practices
Full Job Description
Lead Engineer - Analytical Equipment Validation
Location: On-site, 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:
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.
Commitment to ethical and sustainable practices.
Our full list of global benefits can be found here: https://www.lonza.com/careers/benefits.
What you will do:
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.
Function as CSV SME in inspections and Audits,
What we are looking for:
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.
Ready to shape the future of life sciences? Apply now.
About Lonza America Inc
Lonza America Inc is a subsidiary of Lonza Group, a Swiss multinational company that provides products and services to the pharmaceutical, biotech, and specialty ingredients markets. Lonza America Inc is responsible for the North American market and offers a range of products and services, including custom manufacturing, research and development, and quality control testing. The company has a strong focus on sustainability and has implemented various initiatives to reduce its environmental impact. Lonza America Inc was founded in 1897 and has since grown to become a leading provider of products and services in the pharmaceutical and biotech industries.
