Validation Engineer - Katalyst Healthcares & Life Sciences
Boston, MA 02108
About the Job
Responsibilities :
- Computer Systems Validation.
- Equipment Validation.
- Experience in a multidisciplinary FDA / GMP environment.
- Understanding of compliance and cGMP considerations.
- Strong technical writing and presentation skills.
- Experience in the scale up and operation of large-scale biotechnology processes.
- Implement and maintain the quality system programs that support Validation and Engineering.
- Generate and maintain Engineering and Validation master plans and all associated governing documents
- Develop engineering and validation requirements for the equipment, facilities, utilities and BXP computer systems.
- Represent Validation and Engineering as a member of the Change Review Board supporting the change control process for new projects.
- Direct the completion of validation documentation before changes planned are implemented.
- Manage all utilities systems in accordance with the manufacturer's specifications, EHS and cGMP requirements.
- Provide technical assistance to the facilities maintenance technicians as necessary.
- Will work with Quality to ensure all appropriate documentation, standards and practices are developed and in place for all existing and new systems and processes.
- Review and approve Standard Operating Procedures, specifications, regulatory filings, or other controlled documents as needed to ensure all regulatory and quality requirements are met and maintained.
- Ensure all cGMP guidance targets and standards are achieved as appropriate.
- Oversee the execution of the validation plans using internal and external resources.
- Collaborate with Tech Ops, Quality Control, IT, Supply Chain, GMP Systems and Manufacturing departments for validation planning and communicate the validation standards and requirements.
- Serves as Subject Matter Expert (SME) and point of contact for staff and Regulatory inspections, providing information and guidance on regulations and procedures related to processing equipment and computer system validation.
- Interact with senior management. Can change the thinking of, or gain acceptance from, others in sensitive situations, without damage to the relationship.
Source : Katalyst Healthcares & Life Sciences