Computer Systems Validation Specialist III

About the role

The Computer Systems Validation (CSV) Specialist III leads teams in assessing new and changing computer systems to ensure compliance with company policies and industry guidance. They conduct risk assessments, review change requests and test scripts, draft protocols, and oversee GMP documentation revisions. This role acts as the QA CSV representative for small and large-scale projects while providing technical guidance and mentorship to junior team members.

Responsibilities

• Perform all aspects of QMS process’ – Change Control, Deviations, CAPAs
• Perform Gap assessments to identify the gaps in processes and suggest remediation plans
• Initiate the right Quality records (Deviations and CAPAs) to drive the remediation plan, as needed and execute all responsibilities as CSV project lead for projects
• Author/Review/Approve all end to end Computer system validation life-cycle deliverables/activities
• Schedule qualification activities and personnel to meet business, manufacturing, engineering and quality objectives
• Revise and maintain SOPs to ensure continuous improvement and compliance to GROUP/CORP procedures
• Perform review of Engineering documents (P&IDs, SOPs, Specifications, Submittals, etc.)
• Support Validation requests as a CSV SME, during Customer audits and inspections

Requirements

• Bachelor’s degree in computer science, engineering, or related field
• At least 3+ years of experience in computer systems validation
• 3+ years of Experience in working in a cGMP facility
• Experience with 21 CFR Part 11 and ISPE GAMP guidelines as they relate to Computer Systems Validation (especially for analytical computerized systems)
• Works independently and in teams
• Background in biotech, pharma, or medical device industry
• Ability to work independently and on-site in Portsmouth NH

Qualifications

• 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
• Supportive leadership and mentoring
• Commitment to ethical and sustainable practices

Skills

• Strong knowledge of computer systems validation principles and practices
• Experience with regulatory requirements such as 21 CFR Part 11 and ISPE GAMP guidelines
• Excellent communication and interpersonal skills
• Ability to work independently and in a team setting
• Proficiency in Microsoft Office Suite

Benefits

• Full list of global benefits can be found here: https://www.lonza.com/careers/benefits

Pay

Competitive compensation and benefits package.

Schedule

Not specified.

Application Instructions

Apply now. Reference: R76317

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