Job Summary
We are seeking an experienced engineer with advanced expertise in metrology and validation to support upcoming projects and expansion.
The successful candidate will play a key role in ensuring product and process compliance, supporting facility readiness, and driving continuous improvement in a regulated environment.
* Key Responsibilities:
* Validation
o Develop and execute comprehensive validation protocols (IQ/OQ/PQ) for equipment, processes, and products, ensuring compliance with industry standards (e.g., ISO 13485, FDA).
* Lead and Document Validation Activities
o Lead and document validation activities for new product launches, process changes, and facility expansions.
* Collaborate with Cross-Functional Teams
o Collaborate with cross-functional teams (engineering, quality, manufacturing, regulatory) to ensure validation deliverables are met on time and within scope.
* NPI Project Support
o Act as a technical expert in metrology and validation during NPI project phases, supporting prototype builds, pilot runs, and full-scale production launches.
* Ensure Facility Readiness
o Ensure facility readiness by coordinating equipment qualification, process validation, and documentation with relevant stakeholders.
* Documentation & Compliance
o Maintain accurate and thorough documentation aligned with regulatory, quality, and company standards.
* Prepare Validation Reports
o Prepare validation reports, inspection records, and change control documentation for audits and regulatory submissions.
* Support Internal and External Audits
o Support internal and external audits, including responding to audit observations and implementing corrective actions.
* Continuous Improvement
o Identify and lead process improvement initiatives related to metrology, validation, and NPI activities.
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