Computer Systems Validation Lead Engineer - Lonza Biologics Porrino SLU : Job Details

Computer Systems Validation Lead Engineer

Lonza Biologics Porrino SLU

Job Location : Portsmouth,NH, USA

Posted on : 2025-05-02T00:50:28Z

Job Description :

Computer Systems Validation Lead Engineer

United States, Portsmouth (New Hampshire)

Today, Lonza is a global leader in life sciences operating across five continents. While we work in science, there's no magic formula to how we do it. Our greatest scientific solution is talented people working together, devising ideas that help businesses to help people. In exchange, we let our people own their careers. Their ideas, big and small, genuinely improve the world. And that's the kind of work we want you to be part of.

Job Summary:

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 include risk assessing systems, reviewing change requests and test scripts, drafting protocols, initiating and reviewing GMP documentation revisions, and owning department procedures. The position provides guidance to junior team members.

Key Responsibilities:
  • Lead efforts between internal customers and CSV to ensure activities are prioritized, communicated effectively and timely, and completed on schedule.
  • Maintain full knowledge of Lonza's policies/procedures, 21 CFR Part 11, Data Integrity, ICH Q7A requirements, GAMP, and their underlying principles.
  • Perform all aspects of 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 activities related to qualification and documentation for CSV Validation, ensuring regulatory adherence.
  • Act as a point person for customer communications and assist team members in customer interactions.
  • Develop complex CSV Validation protocols, including Interface Quality and for PCS/MES systems.
  • Mentor and train junior department members.
  • Assess gaps in CSV program compliance and Data Integrity, and establish remediation plans.
  • Support operational phase maintenance of newly implemented computerized systems from a validation perspective.
  • Execute all other assigned duties.
    • Key Requirements:
    • Bachelor's Degree, preferably in Computer Science or Software Engineering.
    • 5-10 years of Computer Systems Validation experience.
    • Experience with 21 CFR Part 11 and ISPE GAMP guidelines related to Computer Systems Validation.
    • Strong written and oral communication skills.
    • Excellent organizational and time management skills.

    At Lonza, our products and services positively impact millions worldwide. We value ethical achievement, respect, and environmental protection. We seek individuals who enjoy solving complex problems and developing innovative solutions in life sciences. We offer the satisfaction of making a meaningful difference and are committed to equal opportunity employment, considering all qualified applicants without discrimination.

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