What are the responsibilities and job description for the Validation Engineer (W2 Only - CAPAs/Deviations) position at Lenmar Consulting Inc.?
Job Description
Must be available to work full time on-site, with occasional nights and weekends.
Bachelor's Degree required
2-5 Years Experience
GMP compliance knowledge
Entry level knowledge of validation lifecycles for computerized systems (CSV), aseptic processing, sterilization validation, and equipment/facility/utility validation.
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. Responsible for the writing of and the execution of project and system qualifications, validation, and re-qualifications/periodic reviews.
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 and specifications/requirements.
Assures that all validation documentation meets or exceeds the regulatory expectations.
Entry level experienced with equipment and/or computer system validation.
Able to work with minimal assistance and supervision on validation discrepancies or investigations.
Performs temperature mapping studies.
Perform other duties as assigned.
Must be available to work full time on-site, with occasional nights and weekends.
Bachelor's Degree required
2-5 Years Experience
GMP compliance knowledge
Entry level knowledge of validation lifecycles for computerized systems (CSV), aseptic processing, sterilization validation, and equipment/facility/utility validation.
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. Responsible for the writing of and the execution of project and system qualifications, validation, and re-qualifications/periodic reviews.
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 and specifications/requirements.
Assures that all validation documentation meets or exceeds the regulatory expectations.
Entry level experienced with equipment and/or computer system validation.
Able to work with minimal assistance and supervision on validation discrepancies or investigations.
Performs temperature mapping studies.
Perform other duties as assigned.
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