CSV Engineer

  • Share :

-5-10 years experience with Computer System Validation
• Validation Master Plans
• 21 CFR 11
• GMP/FDA background
• SOP and Policies - Assure that Validation Department policies and procedures are followed.
Develop Validation Department policies, procedures, and documentation as required.
• VMP’s - Assist in developing site Validation Master Plans including the following:
Company 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.
• Trending - 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.
Periodic Review - Support the implementation and management of the Validation Periodic review program.
• Guidance -Provide guidance and support to all departments as necessary regarding validation related issues, ensuring compliance with 21 CFR 820 QSR, ISO 9001, ISO 13485, 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.
Provide related updates to department management according to the latest EU/US and ICH requirements.
• B.S.
Engineering or B.S/B.A.
from an accredited university.
• Hands on experience in at least 2 validation areas such as computer, process, cleaning, methods, equipment, and utilities.
6+ yrs.
engineering or life sciences experience with 4+ yrs.
in validation.
• Demonstrated technical skill and experience in writing and executing validations in a GMP/cGMP environment.
• Ability to multi-task.
• Capable of generating simple schematics and drawings using Visio, able to manage projects using MS Project.
• Ability to perform training and educate others concerning validation principles.
• Demonstrated success working in a team environment.
Ability to travel.

Read the full job description and apply online on the recuiter's web-site

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