Validation Engineer III

Duration: 12 Months+

• 5-10 Years Experience
• Must be available to work full time on-site, with occasional nights and weekends.
• Bachelor's Degree required
• Need to have CSV computer system validation experience.
• Autoclaves experience is preferred.
• VHP experience is preferred
• GMP compliance expertise required

Requirements:

• Positions will report to the Validation Team management, who will instruct candidate on project scope and priorities. Positions will require someone who can work with several teams and lead the process.
• Previous experience with mechanical validation, computer system validation (CSV), change control, CAPAs/deviations, data integrity, and project management required.
• Support the Validation Manager by ensuring effective implementation and maintenance of the Validation program. Serve as a Validation subject matter expert (SME) and track/report action plan status/completion as it relates to validation systems improvement efforts. Responsible for the writing of and the execution of project and system qualifications, validation, and re-qualifications/periodic reviews.
• Responsibilities:
• Develops validation plans, qualification protocols, compiles and analyzes data, drafts summary reports, and reviews validation documentation to ensure that system are qualified in accordance with applicable regulatory agencies, clients specifications/requirements.
• Assures that all validation documentation meets or exceeds the regulatory expectations.
• Highly experienced with equipment and/or computer system validation.
• Able to work with minimal assistance and supervision on validation discrepancies or investigations.
• Able to assess deviations that affect validation with minimal assistance.
• Able to lead change controls for new product/process equipment into the Client’s Houston facility and assess minor change controls with minimal assistance.
• Able to work with minimal assistance on moderate Corrective Action Preventive Action (CAPA) that result from deviations, internal audits, protocol discrepancies, global quality audits or regulatory inspections.
• Experience with autoclaves and VHP systems.
• Able to speak in audits as a Validation SME.
• Perform other duties as assigned.

Shift: Day