Analytical Equipment Validation Lead Engineer

Lonza, Inc. • Portsmouth, NH

37d

About The Position

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.

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

Benefits

• An agile career and dynamic working culture.
• An inclusive and ethical workplace.
• Compensation programs that recognize high performance.
• Medical, dental and vision insurance.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Professional, Scientific, and Technical Services
• Number of Employees: 5,001-10,000 employees