Validation Engineer (6947265)
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This position is responsible for validation deliverable to meet the needs of customers, projects, and commercial production. This position is responsible for insuring that the validation activities are performed to the appropriate levels of cGMP, ISO and FDA compliance.
Write and execute validation documents for equipment, instruments, facilities, utilities, processes, and test methods in
accordance with the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs. The position is also responsible for the analysis of data, completion of validation protocols, and protocol and validation plan summary reports.
Participation on various project teams will be required. The Validation Engineer provides validation guidance and training to operations. The Validation Engineer manages documentation for validation qualification procedures and technical reports including IQ/OQ/PQ.
- Assists with the creation of and reviews validation and /or qualification procedures and technical reports associated with both process validation and equipment qualification activities.
Creates validation reports to ensure compliance with ISO and FDA regulation requirements.
- Writes/revises or reviews /approves validation life-cycle documents. Document types include but are not limited to validation plans, validation protocols, equipment qualification (IQ/OQ/PQ), process validation, cleaning validations, requirement specifications, method validations, SOPs, work instructions and forms, investigations, validation deviations, CAPAs, any pertinent test data, and validation reports.
- Design and/or specify inspection and testing procedures/systems to ensure products conform to specifications and quality standards.
- Participate with investigation and analysis of customer complaints as requested by Quality Engineer and Quality Engineering Technician.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.