CSV Engineer: Validation & Compliance Lead

Lonza

Portsmouth (NH)

On-site

Confidential

Full time

14 days+

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Benefits offered by this job

Competitive salary

Comprehensive benefits package

Opportunities for career development

Supportive team environment

Access to cutting-edge technology

Inclusive workplace culture

Recognition for contributions

Job summary

Lonza is seeking a Computer Systems Validation Engineer located in Portsmouth, NH. This pivotal role involves implementing industry best practices and oversight of quality systems management. Ideal candidates will have at least 5 years of relevant experience and a degree in a technical discipline.

Responsibilities include leading efforts in CSV, participating in audits, and mentoring junior staff. The position offers competitive salary and comprehensive benefits within a supportive work environment.

Qualifications

Minimum of 5 years of experience with automation and computerized system validations.
Minimum of 2 years’ experience with Controls Automation, Distributed Systems, and MES.
Prior experience leading or managing projects is beneficial.

Responsibilities

Lead efforts between internal customers and CSV for prioritizing activities.
Accountable for maintaining knowledge of policies, regulations, and industry standards.
Perform Quality Systems Management processes and Validation Maintenance.
Participate in audits and inspections as a Subject Matter Expert.
Own, revise, and maintain computer systems validation SOPs.
Mentor and train junior department members.