Responsibilities:

• Perform qualification and validation of lab equipment (e.g., balances, incubators, autoclaves, HPLCs, TOCs, pH meters, etc.).
• Develop and execute equipment qualification protocols (IQ/OQ/PQ) in accordance with regulatory and company requirements.
• Perform impact and risk assessments for lab instruments and systems.
• Author and revise validation documents including Validation Plans, Protocols, Reports, SOPs, and User Requirements Specifications (URS).Support equipment lifecycle management and change control processes.
• Review vendor-supplied documentation (FAT/SAT protocols, manuals, calibration certificates, etc.).
• Collaborate with cross-functional teams (QC, QA, IT, Engineering) to ensure validation project timelines and quality expectations are met.
• Participate in deviation investigations and CAPA related to equipment qualification failures or non-conformances.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and applicable GAMP 5 guidelines.
• Maintain proper documentation and traceability in line with Data Integrity (ALCOA+) principles.
• Support regulatory inspections and internal audits related to lab equipment qualification.

Requirements:

• Bachelor’s degree in engineering, Life Sciences, Chemistry, or a related technical field.
• 3–7 years of experience in equipment qualification/validation in a GMP-regulated pharmaceutical, biotech, or medical device environment.
• Strong hands-on experience with qualification of lab instruments and computerized systems.
• Proficiency with validation lifecycle documents (IQ/OQ/PQ) and quality systems.
• Experience with cGMP, FDA, ICH Q8–Q10, GAMP 5, and 21 CFR Part 11 compliance.
• Strong technical writing and documentation skills.
• Ability to work independently and manage multiple priorities.
• Experience with validation software tools such as Val Genesis, Knead, or Track Wise.
• Familiarity with data integrity assessments and ALCOA+ principles.
• Experience supporting regulatory audits (FDA, EMA, etc.).
• Knowledge of analytical laboratory workflows.

• Perform qualification and validation of lab equipment (e.g., balances, incubators, autoclaves, HPLCs, TOCs, pH meters, etc.).
• Develop and execute equipment qualification protocols (IQ/OQ/PQ) in accordance with regulatory and company requirements.
• Perform impact and risk assessments for lab instruments and systems.
• Author and revise validation documents including Validation Plans, Protocols, Reports, SOPs, and User Requirements Specifications (URS).Support equipment lifecycle management and change control processes.
• Review vendor-supplied documentation (FAT/SAT protocols, manuals, calibration certificates, etc.).
• Collaborate with cross-functional teams (QC, QA, IT, Engineering) to ensure validation project timelines and quality expectations are met.
• Participate in deviation investigations and CAPA related to equipment qualification failures or non-conformances.
• Ensure compliance with FDA 21 CFR Part 11, EU Annex 11, and applicable GAMP 5 guidelines.
• Maintain proper documentation and traceability in line with Data Integrity (ALCOA+) principles.
• Support regulatory inspections and internal audits related to lab equipment qualification