Senior Validation Specialist

2 weeks ago


Santa Monica, California, United States Genovice Full time
{"h1": "Lead Validation Engineer - GMP Quality Lead", "p": "At Genovice, we are seeking a highly skilled Lead Validation Engineer to lead a critical GMP consulting project at our client\u2019s site. This role involves overseeing the implementation of comprehensive quality systems, regulatory compliance, equipment/process validation, and technology transfer.

Key Responsibilities:

* Lead the design, development, and implementation of validation protocols for equipment, processes, and products within the project.
* Provide senior-level expertise on GMP regulatory requirements, including Title 21 of the CFR, EMA EudraLex, and ISO 9001:2015 standards.
* Oversee quality systems implementation, ensuring all procedures meet regulatory standards and are prepared for future scalability.
* Develop and review key quality documents, including Quality Plans, Validation Protocols, and Batch Records.
* Conduct internal audits and provide strategic guidance on preparing for external inspections by regulatory bodies.
* Mentor and oversee the junior validation/quality engineer and staff on validation practices and regulatory requirements.
* Ensure clear documentation and record keeping practices that support GMP compliance.
* Collaborate with scientific, operational, and quality teams to streamline and standardize processes.

Requirements:

* Bachelor\u2019s or Master\u2019s degree in Engineering, Biotechnology, Life Sciences, or a related field.
* Minimum of 10+ years of experience in GMP validation, regulatory compliance, and quality systems implementation.
* Extensive knowledge of GMP regulations (CFR Title 21, EMA EudraLex), and ISO 9001:2015 standards.
* Proven experience in leading complex validation projects in a regulated environment, including product and process validation.
* Strong leadership, project management, and mentoring skills.
* Excellent communication and collaboration abilities.
* Experience in technology transfer and regulatory interactions is highly desirable.

Preferred Certifications:

* ASQ Certified Quality Engineer (CQE) or Certified Quality Auditor (CQA)
* Six Sigma Black Belt or equivalent process improvement certification
"}

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