The ideal candidate will have at least 7 years as a computer systems validation engineer either at a software company or in a FDA regulated company.

Job Description

• Perform computer validation activities in support of the Quality Service Organization
• Develop validation plans/approach/policy
• Project Management/Execution of validation activities

• Working with the client and our development team to develop validation estimates, resource requirements and detailed project plans.
• Oversee the validation projects from needs analysis to go-live.
• Perform or review and approve computer validation activities and other Quality Assurance activities.
• 21 CFR Part 11 assessments/remediation activities.
• Defend Quality Assurance program during external audits.
• Requires experience generating/reviewing/approving requirements and design specifications, and creating/executing/approving test protocols (IQ/OQ/PQ).
• Oversee adherence to Project Management Office (PMO) delivery & risk mitigation standards.
• Develop a tight and concise communication plan. Manage the plan especially with respect to issues and escalations.
• Conduct customer presentations around our validation products and services.

 Job Qualifications

• A bachelor's degree in Information Systems or Sciences
• PMI certification desirable.

• Minimum of 7+ years working experience in a similar role for software vendors or FDA regulated companies.
• Experience managing validation projects from a delivery perspective.
• Knowledge of Quality Management Systems in the FDA industry.
• Strong Project Management skills and experience
• Oral communication skills that can be universally described as eloquent, articulate and lucid.
• Written communication skills of publication-level quality (white papers, blogs, etc.)
• Excellent organization and interpersonal skills
• Ability to work with remote teams.