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Advanced Technical Validator
3 weeks ago
At the heart of our organization, we seek a Senior Validation Lead to oversee and manage the validation lifecycle for our manufacturing processes. This pivotal role will be responsible for leading the design transfer process and ensuring the technical aspects of the validation lifecycle are executed effectively.
Responsibilities:
- Lead the validation team in executing technical and equipment validation projects according to predetermined protocols and production requirements.
- Ensure that the design, installation, and operation of plant and equipment have been validated in compliance with current regulatory requirements.
- Develop a strategy to ensure that the validation approach satisfies the requirements of all regulatory bodies; regulations, standards, guidance, and GMP, including effective and appropriate use of process development and DOE activities.
- Produce and maintain comprehensive validation policy and procedures.
- Execute allocated validations according to the plant Validation Master Plan.
- Provide input, monitor, and report compliance on the content of the Validation Master Plan in conjunction with the primary teams, and corresponding Management Reviews.
- Implement validation system documentation as required.
- Review and approve validation lifecycle documentation to ensure they are written in accordance with company standards and procedures.
- Develop and maintain processes and procedures to ensure product and process transfers are achieved efficiently.
- Liaise with Operations, Planning, and Engineering groups to ensure successful validation of all manufacturing processes.
- Manage the activities of a defined team of Validation Engineers. Management responsibilities include day-to-day work allocation, prioritization of work, performance review, coaching, training, internal communications, and general personnel assistance during their duties.
Requirements:
- Bachelor's degree in a relevant field or equivalent experience.
- Minimum 5 years high-volume engineering experience in medical devices.
- Minimum 3 years validation experience.
- Strong working knowledge of statistical techniques, Minitab, Six Sigma (preferably Green Belt), sampling plans/sizes.
- Process development experience (DOE's etc.).
- Risk analysis/risk management, FMEA's, etc.
- Strong documentation skills.
- Ability to work independently and as part of a team.
- Strong interpersonal and communication skills.
- Process validation training and experience.
- Strong technical and problem-solving skills.
