Randstad Validation Engineer in Andover, Massachusetts
salary:$75 - $95 per hour
date posted:Wednesday, January 13, 2021
Long term contract opportunity for a Validation Engineer. This candidate will have Quality Assurance oversight in support of a site project to remediate Data Integrity (DI) commitments. The individual will be responsible for the quality review and approval of validation and change control documentation such as protocols, test plans, various computer validation testing documents, deviations, and change controls in relation to Data Integrity remediation activities.
location: Andover, Massachusetts
job type: Contract
salary: $75 - 95 per hour
work hours: 8am to 4pm
The individual will provide Quality Assurance oversight in support of a site project to remediate Data Integrity (DI) commitments. The individual will be responsible for the quality review and approval of validation and change control documentation such as protocols, test plans, various computer validation testing documents, deviations, and change controls in relation to DI remediation activities. The documentation will span the breadth of validation and change control requirements for biopharmaceutical processing therefore validation and quality assurance experience in an manufacturing GMP environment is required. The individual will also ensure that the execution of documents adheres to the governing SOPs, protocols, project plans, cGMP, etc. Upon completion of their review, the individual will also be responsible for the release of equipment / instruments back to GMP manufacturing.
Provide QA review of executed validation documents such as change controls, protocols and test plans, validation testing documents, and deviations.
Ensure compliance to governing SOPs, validation plans, and protocols throughout the project.
Release equipment and / or instruments for GMP manufacturing and / or Quality Control use as part of change control.
Have the ability to independantly assess impact and re-testing requirements in the event of a deviation.
Interactions will primarily be between Engineering/Validation personnel. Some interaction will also occur with operation and / or quality control lab personnel and, as applicable
Proficient in reviewing executed validation documents (change controls, protocols and test plans, validation testing documents, deviations, etc.)
Knowledge of cGMP regulations as they pertain to the pharmaceutical/biopharmaceutical industry.
Thorough understanding of the computer validation lifecycle including change control
Identify and address any potential quality impact throughout the project
Position will be office/desk based. Position is first-shift with potential for second shift / weekend coverage, on occasion. No travel from the site is required.
Experience level: Experienced
Minimum 8 years of experience
Education: Bachelors (required)
QC Micro (3 years of experience is preferred)
lab instrument validation
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
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