Validation Engineer III

Responsibilities

• Independent drafting and execution of complex validation plans, protocols, and test strategies to ensure compliance and expedited release of critical site equipment. The candidate is an experienced professional requiring minimal assistance from more experienced colleagues, balancing competing priorities while ensuring globally generated work is conducted per regulatory requirements and company procedures.
• Serve on assigned internal and external project teams (change controls, deviations, technology transfer) as a technical/compliance resource to solve quality related issues and/or support continuous improvement.
• Train personnel in quality and validation principals.
• Support Engineering and departments in the selection, review, acquisition, and upgrade of systems and production equipment. Provide technical support in developing user and functional requirements specifications, URS, RA, FRS and DQ for systems and equipment.
• Serve as Lead Validation representative on assigned project teams and communicate new requirements/perform training with Validation team to assure all timelines are met resulting in successful project completion and new product launches.
• Utilize industry experience and knowledge to support Production and Engineering. Share quality philosophies throughout Operations.
• Utilize industry experience, knowledge and procedures to support Engineering and Production.
• Performs all company business in accordance with all regulations (e.g. EEO, FDA, etc.) and Company policy and procedures. Demonstrated high ethical and professional standards with all business contacts in order to maintain BIAH's reputation in the community. When violations are noted or observed, they are immediately reported to management.
• Successfully completes annual training on Compliance Modules as assigned by the Company.
• Training completion is monitored on a monthly basis through KPI reporting to Quality management.
• Room Qualification and Smoke studies in grade A pharmaceutical facilities.
• Media fill qualifications oversight and support.
• Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and warehouse areas.
• Extensive experience with Ellab data loggers and software.
• Extensive technical writing experience to independently write and execute protocols and complete final reports (minimal oversight from validation reviewer).
• Comprehensive knowledge and understanding of cleaning validation concepts and principles.
• Comprehensive knowledge and understanding of pharma grade utilities (water, HVAC, gases).
• Support Maintenance, Engineering and Production Depts. in the selection, review, acquisition, and upgrade of systems and production equipment.
• Provide technical support in developing user and functional requirements specifications, URS, RA, FRS, and DQ for systems and equipment.
• Develops and assists with audit responses and completion of assigned CAPAs by target due dates. Included is the responsibility for making sure Validation areas are "inspection ready" at all times.
• Execute all actions required to support Change Control, Deviation and CAPA on-time closure.

• 6 years GMP validation or similar experience in a GMP manufacturing or similar production environment.
• Minimum of 10 years GMP validation experience in a GMP or regulated manufacturing or similar environment in lieu of a degree.
• Experience must be inclusive of at least 3 years leading projects.
• Ability to plan, schedule, organize, prioritize and coordinate project activities.
• Ability to function in a leadership role and within cross function teams.
• Ability to analyze validation and production data to assess compliance with GMP requirements and/or troubleshoot compliance problems.
• Excellent written and verbal communication skills.
• Excellence in comprehension/application of FDA/EU/USDA regulatory requirements for production and distribution of regulated biological articles.
• Strong theoretical and practical knowledge of regulated processes and one technical discipline, such as biology to apply knowledge or experience to assigned tasks.
• Ability to make decisions regarding the acceptability of product based on documentation provided.
• Demonstrated ability to work with diverse groups of people and conflict management.
• Skillful in using office application software (MS-Word, MS-Excel, MS-Outlook, PowerPoint).

Bachelors, preferably in a science or engineering related field