Role and Responsibilities:
As a Validation Engineer, you will be responsible for planning, executing, and maintaining validation activities for equipment, systems, and utilities in compliance with FDA, EU, and ICH guidelines.
You will collaborate with cross-functional teams to ensure all systems meet regulatory requirements and support continuous improvement of validation processes.
Validation Planning and Execution:
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Develop and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols for equipment and systems.
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Lead validation efforts for manufacturing, cleaning, and laboratory equipment to ensure compliance with internal and external standards.
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Author and update Validation Master Plans (VMPs), SOPs, and technical reports.
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Conduct risk assessments and deviation investigations related to validation activities.
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Ensure validation documentation aligns with FDA, EU, and ICH regulatory guidelines.
Compliance and Cross-Functional Support:
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Provide validation support during audits and inspections, ensuring readiness and compliance.
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Collaborate closely with Quality Assurance (QA), Engineering, Manufacturing, and R&D teams to achieve validation objectives.
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Support continuous improvement by identifying opportunities to optimize validation procedures and documentation practices.
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Maintain compliance with CDISC, ICH GCP, and 21 CFR Part 11 throughout all data processes.
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Lead and contribute to the development of departmental SOPs, data standards, and process improvements.
Compliance and Quality Oversight:
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Ensure data management activities meet global regulatory and quality standards (FDA, EMA, PMDA).
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Support inspection readiness and risk-based quality management (RBQM).
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Partner with cross-functional teams to implement data governance frameworks and uphold data integrity.
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Apply best practices in clinical data compliance, CDASH, and validation standards such as Pinnacle21.
Required Skills:
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Bachelor’s degree in Engineering, Life Sciences, or a related technical field.
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2–5 years of hands-on experience in validation within the pharmaceutical or biotech industry.
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Strong understanding of cGMP, FDA, 21 CFR Part 11, ICH Q7/Q8, and Annex 15 compliance standards.
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Skilled in writing clear and compliant protocols and validation reports.
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Excellent problem-solving and multitasking abilities in a fast-paced environment.
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Experience with equipment, facility, cleaning, or software validation preferred.