Lead Engineer - Analytical Equipment Validation

Lonza Group Ltd.; Portsmouth (NH); On-site; USD 120,000 - 180,000; Full time

Benefits offered by this job

Collaborative environment

Career growth opportunities

Cutting-edge technologies and tools

Competitive compensation

401(k) matching plan

Ethical and sustainable practices

Job summary

Lonza Group Ltd. is seeking a Lead Engineer - Analytical Equipment Validation to drive computer systems validation within GMP frameworks at our Portsmouth, NH site.

You will lead cross-functional CSV activities, assess risks, and oversee change controls and data integrity in accordance with 21 CFR Part 11 and ISPE GAMP guidance. The role requires a Bachelor’s degree in a computer science/engineering field and 5–10 years of CSV experience, with strong communication skills and a track record of

Qualifications

• Bachelor’s degree in a related field.
• 5–10 years of Computer Systems Validation experience.
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines.
• Strong written and oral communication 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.

Skills

CSV leadership

Regulatory knowledge

Risk assessment

Written communication

Education

Bachelor’s Degree in Computer Science/Software Engineering

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.

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 of 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.

Ready to shape the future of life sciences?