Lead Computer Systems Validation (CSV) Engineer (W)

About the role

The role of the Lead Computer Systems Validation (CSV) Engineer involves leading the validation activities for computer systems used in regulated environments. This includes ensuring compliance with regulatory standards such as FDA CFR Part 11 and ISO 13485.

Responsibilities

• Oversee the validation process for computer systems used in regulated environments.
• Ensure compliance with regulatory standards such as FDA CFR Part 11 and ISO 13485.
• Collaborate with cross-functional teams including IT, Quality Assurance, and Regulatory Affairs.
• Develop and maintain validation documentation and procedures.
• Train and mentor junior members of the team on validation methodologies and best practices.

Requirements

• Bachelor’s degree in Computer Science, Engineering, or related field.
• Minimum of 5 years of experience in computer systems validation or equivalent.
• Experience with FDA CFR Part 11 and ISO 13485 regulations.
• Strong understanding of software development lifecycle and quality assurance principles.
• Excellent communication and interpersonal skills.

Qualifications

• Proven leadership skills in managing validation projects.
• Experience with validation tools and software.
• Knowledge of industry-standard validation methodologies.
• Ability to work independently and manage multiple tasks simultaneously.

Skills

• Proficient in Microsoft Office Suite.
• Experience with validation software tools such as Oracle, SAP, etc.
• Strong analytical and problem-solving skills.
• Excellent written and verbal communication skills.

Benefits

• Competitive salary package.
• Flexible working hours.
• Professional development opportunities.
• Health insurance coverage.
• Employee discounts.

Pay

$80,000 - $100,000 annually based on experience.

Schedule

Full-time, Monday through Friday, 9 AM to 5 PM.

Contact

To apply, please submit your resume and cover letter.