What are the responsibilities and job description for the Validation Engineer II position at Kellton?
Position: Validation Engineer II
Pay Rate: $50/ hr on W2
Duration: 12 months contract
Location: Houston, TX 77047
US Citizen, GC only
This role requires full-time on-site availability, with occasional nights and weekends. A Bachelor's Degree is mandatory for this position.
Key Qualifications
Significant experience in CSV computer system validation.
Preferred experience with autoclaves and VHP (Vaporized Hydrogen Peroxide) systems.
GMP compliance expertise.
Previous experience with mechanical validation, change control, CAPAs/deviations, data integrity, and project management.
Ability to work with multiple teams and lead the validation process.
Responsibilities
Report to Validation Team management for project scope and priorities.
Work with multiple teams and lead the validation process.
Support the Validation Manager in implementing and maintaining the Validation program.
Serve as a Validation subject matter expert (SME) and track/report action plan status/completion related to validation systems improvement efforts.
Write and execute project and system qualifications, validations, and re-qualifications/periodic reviews.
Develop validation plans, qualification protocols, compile and analyze data, draft summary reports, and review validation documentation.
Ensure systems are qualified in accordance with regulatory agencies, clients, and *** specifications/requirements.
Assure that all validation documentation meets or exceeds regulatory expectations.
Highly experienced with equipment and/or computer system validation.
Work independently on validation discrepancies or investigations with minimal assistance and supervision.
Assess deviations affecting validation with minimal assistance.
Lead change controls for new product/process equipment into the *** Houston facility and assess minor change controls with minimal assistance.
Work independently on moderate Corrective Action Preventive Action (CAPA) resulting from deviations, internal audits, protocol discrepancies, global quality audits, or regulatory inspections.
Experience with autoclaves and VHP systems.
Speak as a Validation SME in audits.
Perform other duties as assigned.
Pay Rate: $50/ hr on W2
Duration: 12 months contract
Location: Houston, TX 77047
US Citizen, GC only
This role requires full-time on-site availability, with occasional nights and weekends. A Bachelor's Degree is mandatory for this position.
Key Qualifications
Significant experience in CSV computer system validation.
Preferred experience with autoclaves and VHP (Vaporized Hydrogen Peroxide) systems.
GMP compliance expertise.
Previous experience with mechanical validation, change control, CAPAs/deviations, data integrity, and project management.
Ability to work with multiple teams and lead the validation process.
Responsibilities
Report to Validation Team management for project scope and priorities.
Work with multiple teams and lead the validation process.
Support the Validation Manager in implementing and maintaining the Validation program.
Serve as a Validation subject matter expert (SME) and track/report action plan status/completion related to validation systems improvement efforts.
Write and execute project and system qualifications, validations, and re-qualifications/periodic reviews.
Develop validation plans, qualification protocols, compile and analyze data, draft summary reports, and review validation documentation.
Ensure systems are qualified in accordance with regulatory agencies, clients, and *** specifications/requirements.
Assure that all validation documentation meets or exceeds regulatory expectations.
Highly experienced with equipment and/or computer system validation.
Work independently on validation discrepancies or investigations with minimal assistance and supervision.
Assess deviations affecting validation with minimal assistance.
Lead change controls for new product/process equipment into the *** Houston facility and assess minor change controls with minimal assistance.
Work independently on moderate Corrective Action Preventive Action (CAPA) resulting from deviations, internal audits, protocol discrepancies, global quality audits, or regulatory inspections.
Experience with autoclaves and VHP systems.
Speak as a Validation SME in audits.
Perform other duties as assigned.
Salary : $50
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