The Senior 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. 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.
SOP and Policies
- 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.
- 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. Able to accurately assess the scope of work, timing and resource requirements as it pertains to validation activities within projects.
- Assist in providing related training and support. Assist in completing applications for regulatory approval.
- 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.
- Support the implementation and management of the Validation Periodic review program.
- 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. Provide related updates to department management according to the latest EU/US and ICH requirements.
- 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 by car and/or plane, given sufficient notice, typically up to 10%. Additional travel may be required based on business need.
EDUCATION and/or EXPERIENCE
- 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.