Senior Quality Validation Engineer II

Overview

The Validation Engineer ensures the reliability, consistency, and compliance of our processes, equipment, and systems to meet regulatory requirements and quality standards. This role mainly drives the review of validation documentation, including Validation Plans, User Requirements Specifications, Installation and Operational Qualification Protocol, Performance Qualification Protocols and Validation Summary Reports and ensuring that these are compliant with the regulations and/or standards. This includes supporting validation of processes, equipment, cleaning, and computer systems.

The Quality Validation Engineer also provides assistance and mentorship to system owners and Validation Engineers with impact risk assessments to identify the qualification and validation requirements, on equipment before returning or handing over to the system owner and assist in arranging external services when required.

• Review and approve validation plans for both new and existing processes, equipment, and systems.
• Review and approve qualification protocols for equipment qualifications and process validations and subsequent reports. This includes ensuring that the performance criteria are compliant with safety and quality standards.
• Work with the Validation Engineers to troubleshoot any issues and/or deviations encountered during the execution of the protocol.
• Support company’s Master Validation Plan (MVP) and perform periodic reviews to ensure that it still aligns with the current regulations and the Validation Program requirements.
• Conduct periodic reviews and updates of the Validation Program for compliance with applicable regulations and standards.
• Collaborate with cross-functional teams to provide quality-related guidance, solve technical problems, and contribute to project milestones.
• Conduct data analysis and make recommendations to ensure tissue safety/quality and compliance with standards.
• Conduct trending analysis of relevant quality metrics to recommend initiatives for improvement and/or corrective actions, as applicable.
• Work with the Validation Engineers to assess the impact of process, material, or equipment changes on validation status and provide guidance on revalidation or change control measures.
• Work with the Validation Engineers to identify potential risks associated with manufacturing processes and implement appropriate mitigation measures to minimize those risks effectively.
• Offer expertise and support to other departments on validation-related matters.
• Support compliance investigations and recommend corrective and preventive actions, as needed.
• Ensure personal and company compliance with all federal, state, company and regulatory bodies’ regulations, policies, and procedures.
• Mentor and guide other engineers, fostering their technical growth and professional development.

• Bachelor’s degree in engineering or a related technical discipline (e.g. Biology, Chemistry, etc.). Proficiency in microbiology preferred.
• At least 5-6 years of experience in related Engineering or Quality role. Experience in validations preferred.
• Strong knowledge of ISO 13845, FDA, AATB, and cGTP guidelines preferred.
• Experience in Tissue Banking, Pharmaceutical, Medical Device, or Biologics industry.
• Experience with Non-Conformance, Deviation, Complaint, and Corrective and Preventive Actions (CAPAs) preferred.
• Strong knowledge of relevant software applications (Microsoft Project, Word, Excel, and PowerPoint).
• Effective oral, written, communication, and presentation skills.
• Strong analytical and problem-solving skills.
• Project management skills preferred.
• Ability to be assertive and influence others and lead significant changes.
• Experience working with peptides a plus.

Must be willing to accommodate travel if necessary. Office environment, laboratory environment, occasional clean room access, subjected to human tissue and associated hazards and biohazards.

While performing the duties of this job, the employee is regularly required to sit for prolonged periods of time. The employee may occasionally be required to pull, lift and/or move up to 20 pounds.

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