Responsible for developing and implementing validation and qualification policies, procedures, and protocols. Reviews and analyzes protocol data to ensure compliance with requirements. Prepares and submits protocol reports for internal and external review. Oversees the change control process for critical equipment and systems and develops master validation plans.
Key Responsibilities:
* Develops validation and qualification protocols and tracks execution in alignment with project timelines.
* Leads validation activities across all phases, including FAT, IQ, SAT, OQ, and PQ.
* Reviews and approves validation documentation to ensure compliance with site validation requirements.
* Analyzes protocol data, resolves discrepancies, and addresses deviations during execution.
* Prepares and submits validation reports for review and approval.
* Manages validation and qualification strategies for equipment and processes.
* Maintains and administers change control programs for critical equipment and systems.
* Identifies and implements improvements in validation and qualification programs.
* Develops and maintains system-level documents, including master validation plans, policies, and procedures.
* Applies statistical techniques, such as process capability and Gauge R&R.
* May require travel depending on project needs.
* Continuously seeks process improvements and maintains a quality-first mindset.
* Supports lean manufacturing principles and quality programs.
* Ensures adherence to quality system requirements and data integrity principles.
* Maintains compliance with all safety policies and regulatory requirements.
* Adheres to company values and behaviors.
* Additional responsibilities may be assigned as required.
Job Requirements:
* Bachelor’s degree in Engineering or equivalent.
* 4-6 years of experience in validation or qualification within a regulated industry.
* Working knowledge of ISO 13485:2016 or equivalent.
* Familiarity with 21 CFR 820, 21 CFR 210/211, and Part 11 is a plus.
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