Job Description

Job Description

Job Description

Roles & Responsibilities:

• Ensure all qualified and validated equipment/systems comply with company policies, guidelines, and procedures.
• Develop and execute equipment qualification and validation protocols, supporting calibration and validation activities.
• Configure, document, and manage the lifecycle of computerized systems, ensuring compliance with CSV requirements.
• Create validation documentation, including Validation Plans, User Requirement Specifications, Traceability Matrices, Summary Reports, and Change Controls.
• Oversee laboratory and manufacturing equipment implementation projects, managing timelines, procurement, installation, qualification, and turnover.
• Independently manage qualification and CSV activities for single and multi-user systems.
• Supervise vendors performing qualification activities, ensuring compliance with regulatory and company standards.
• Provide technical support on calibration, equipment procurement, maintenance, and lifecycle management.
• Maintain accurate and precise validation documentation in line with company and regulatory standards.
• Respond to qualification and support requests promptly, maintaining strong client relationships and fostering a collaborative team environment.

• Bachelor's degree in Engineering, Computer Science, or a related field (required).
• Minimum of 5 years' experience in an FDA-regulated industry, with at least 3 years in Computerized System Validation (CSV).
• Experience with QC analytical equipment (e.g., plate readers, cell counters, flow cytometers) is a plus.
• In-depth knowledge of regulatory requirements, including FDA, EMA, ICH guidelines, and 21 CFR Part 11.
• Proficiency in cGXP, ISPE guidelines, good documentation practices, and equipment qualification processes.
• Strong analytical, problem-solving, and communication skills.
• Team-oriented mindset, capable of collaborating effectively with cross-functional teams including Engineering, QC, and QA.

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