Senior Validation Engineer
18 hours ago
We are seeking an experienced Senior Validation Engineer to join our team at Gahagan & Bryant Associates Inc. The ideal candidate will have a strong background in CSV, automation, and validation principles, with expertise in sterile/aseptic facility CQV and thermal mapping experience.
Responsibilities- Support client commissioning/validation for facility, utility, equipment, cleaning, and process validation projects
- Prepare and execute commissioning/validation lifecycle documents
- Participate in 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
- Manage and execute multiple projects to meet client priorities
- Provide a practical approach to problem-solving
- Bachelor's degree in a related life sciences or engineering field
- Years of GMP experience
- Ability to converse about scientific matters
- Candidate must have sterile/aseptic facility CQV experience
- Thermal mapping experience is essential
- Sterilization/SIP experience a plus
- 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
- Experience with Sterile/Aseptic Filling
- Experienced with all pertinent industry best practices, including development and execution of all applicable system life cycle deliverables
- Demonstrated expertise in at least one aspect of system qualification and regulatory compliance
- Excellent written communication skills with emphasis in technical writing
- Proficient in Microsoft Word, Excel, PowerPoint, and Project
- Must be willing to travel regionally and/or nationally throughout the U.S.
- Candidate must be on-site during core hours M-F from 7am-3pm
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