Responsibilities :
- Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects.
- Prepare and execute commissioning / validation lifecycle documents.
- Participate in any stage of clinical or commercial production including green field construction, facility renovation, new product development, product launch, or product / process upgrade.
- Write summary reports for validation and qualification protocols.
- Support project milestones, priorities and deadlines.
- Write operating procedures for technical equipment and practices and procedures.
- Perform system and process risk assessments and analyses.
- Schedule and coordinate protocol execution with other departments including manufacturing, facilities and project management.
- Develop project specific validation plans and strategy.
- Able to manage and execute multiple projects to meet client's priorities.
- Provide a practical approach to problem solving.
- Individuals must represent COMPI at client sites and interact confidently with clients, contractors, management and peers.
Requirements :
- Bachelor's degree in a related life sciences or requisite industry training and experience.
- years GMP experience.
- Ability to converse about scientific matters.
- Ability to work independently or in collaboration with others.
- In depth understanding and application of validation principles, concepts, practices and standards.
- Considered a Subject Matter Expert (SME) in one area of validation.
- Proficient in current Good Manufacturing Practices and other applicable regulations.
- Experienced with all pertinent industry best practices (, ISPE) including development and execution of all applicable system life cycle deliverables (, URS, SRS, FRS, DDS, RTM, Unit, Integration.
- User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report.
- Demonstrated expertise in at least one aspect of system qualification and regulatory compliance (, EMEA, GCP, GLP, GMP, QSR) and internal requirements employing regulatory guidance and industry standards.
- Excellent written communication skills with emphasis on technical writing.
- Proficient in Microsoft Word, Excel, Power Point and Project.
Senior Validation Engineer
Support Client commissioning / validation for facility, utility, equipment, cleaning and process validation projects. User Acceptance testing, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report. Prepare and execute commissioning / validation lifecycle documents. Write summary...
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