Job Description

Job Responsibilities:

• Provide lifecycle management for Quality Control lab instruments and related software systems.
• Revise and/or obsolete validation documents and Standard Operating Procedures (SOPs).
• Provide validation services for laboratory analytical instruments and controlled temperature units (CTU), including writing, editing, executing protocols, and reviewing vendor validation documents in accordance with site validation requirements.
• Perform change control management activities, including authoring, performing, and tracking change actions.
• Create and perform investigations for Deviations and CAPAs.
• Perform instrument periodic reviews.
• Escort onsite vendors performing laboratory instrument maintenance.
• Design and execute validation protocols (IQ/OQ/PQ) for equipment, utilities, and processes.
• Analyze test data and determine whether systems meet predefined acceptance criteria.
• Document validation activities and maintain records in accordance with regulatory guidelines.
• Collaborate with cross-functional teams to support product development and process improvements.
• Ensure compliance with industry standards such as FDA, ISO, and cGMP.
• Participate in audits and inspections, providing validation documentation and responses.
• Stay current with validation trends, technologies, and regulatory updates

Skills:

• Strong analytical and problem-solving abilities.
• Knowledge of validation principles, quality systems, and regulatory requirements.
• Proficiency in statistical analysis tools and validation software.
• Excellent written and verbal communication skills.
• Ability to work independently and manage multiple projects.
• Familiarity with laboratory and manufacturing environments.

Education/Experience:

• Bachelor’s degree in Engineering, Life Sciences, or a related field required.
• 5–7 years of experience in validation, quality assurance, or process engineering.

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