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Senior Validation Engineer

Company: CyberCoders
Location: Bethlehem
Posted on: May 18, 2020

Job Description:

Senior Validation Engineer
Senior Validation Engineer needed for a leader in diagnostic detection tools in the medical device industry!!We support the the development, manufacture and distribution of oral fluid diagnostic and collection devices and other technologies designed to detect or diagnose critical medical conditions. Our portfolio of products is sold globally to various clinical laboratories, hospitals, clinics, community-based organizations and other public health organizations, research and academic institutions, distributors, government agencies, physicians' offices, and commercial and industrial entities. As a Senior Validation Engineer, you will assure that all validation documentation meets or exceeds the regulatory expectations set forth by 21 CFR Part 820, ISO 9001 and ISO 13485. The Senior Validation Engineer will be able to independently write, execute, and summarize validations in the following areas, Equipment, Utilities, Process, Cleaning, Computer, Methods, Packaging, etc., and will ensure that all goods manufactured by the Company meet the quality requirements of the Company, Regulatory Agencies, and Notified Bodies.

What You Will Be Doing
- 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 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.- Serve as the validation representative on project teams to ensure all departments understand and comply with the requirements of cGMPs as applied to the Company's products, regulatory requirements and internal validation policies/procedures.- Support the implementation of Validation Key Performance Indicator(s). Monitor trends and initiate Continuous Improvement opportunities. Escalate any out-of-norm matters to department management as applicable.- Perform technical reviews and interpret data of completed validations and change controls to determine system impacts and re-validation requirements.- Provide guidance and support to all departments as necessary regarding validation related issues, ensuring compliance with 21 CFR 820 QSR, ISO 9001, ISO 13485, MDSAP and all other Quality Standards and Validation Regulations and Guidance Documents.- Maintain on-going understanding and knowledge of the latest regulatory requirements for validation in compliance with EU/US regulations and guidance documents.
What You Need for this Position
- Bachelors of Science or Master's degree in Engineering or a related discipline- 4+ years of engineering or life sciences experience - 2+ years of experience in validation.You should know some of the following:- Medical/ Life Sciences- GMP/cGMP- Validation Principles- Validation Master Plan (VMP)- IQ/PQ/OQ- 21 CFR 820 QSR- ISO 9001- ISO 13485- Medical Device Single Audit Program (MDSAP)
What's In It for You
- Competitive compensation and base salary- Full benefits: Medical, Dental, Vision- 401 (K) with generous company match- Life Insurance coverage- Paid time off (PTO)- Vacation, sick, and paid holidays

1. Apply directly to this job opening here!or2. E-mail directly for more information to
- Applicants must be authorized to work in the U.S.
CyberCoders, Inc is proud to be an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, or any other characteristic protected by law.

Your Right to Work In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.

Keywords: CyberCoders, Bethlehem , Senior Validation Engineer, Engineering , Bethlehem, Pennsylvania

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