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Validation Engineer (7336360)

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Job Description
Seeking a validation engineer with experience in regulated environment and computer systems, equipment and utilities validation. Strong technical writing background is preferred. The validation engineer will assure that all validation documentation meets or exceeds the regulatory expectations set forth by 21 CFR part 820, ISO 9001 and ISO 13485.
Responsibilities


  • Assure that Validation Department policies and procedures are followed.

  • Develop Validation Department policies, procedures, and documentation as required.

  • Assist in developing site Validation Master Plans including the following: OTI Site VMP, Equipment Qualification VMP, Cleaning VMP, Process VMP, Methods VMP, Packaging VMP, and any other project VMPs which may be required.

  • Support the implementation, compliance with, completion of, and reporting of all Validation Master Plans.

  • Support all areas requiring Validation. Prepare, review, and complete protocols, reports, and other document as required. Ensure compliance with regulatory requirements and departmental and organizational objectives.

  • Ensure all departments understand and comply with the requirements of cGMPs as applied to the Company's products. Assist in providing related training and support. Assist in completing applications for regulatory approval.

  • Perform Risk Assessments and Failure Modes and Effect Analysis for new equipment, processes, or significant changes to existing processes.

  • Assist with the investigation and remediation of the internal CAPA program.

  • Conduct root cause analysis and deviation resolution.

  • Develop, author, and execute DOEs, Engineering Protocols, and Manufacturing Studies employing appropriate statistical analysis and sample size rationale.


Requirements

  • BS Engineering OR BA/BS in life science.

  • 4 years validation experience (equipment, computer systems, utilities)

  • Degree not super critical if experience is there.









About Aerotek:
Your success starts with the right career opportunity. Aerotek uses a people-focused approach to connect job seekers to incredible opportunities with leading organizations. Established in 1983, we've grown to become a consistent Best of Staffing winner for talent satisfaction because of our dedication to exceptional service. Serving over 300,000 contract workers every year, we specialize in placing workers with engineering, scientific, professional and industrial skill sets. Aerotek is proud to offer competitive benefits, including contributory medical, dental and vision insurance, weekly pay, discounts on consumer goods and services and more.

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