Summary:

CSV Specialist - C&Q Lab. to support the qualification and validation of laboratory and manufacturing equipment in compliance with regulatory requirements. 

Key Responsibilities:

• Develop and execute CSV documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and Validation Reports.

• Lead or support validation projects for newly acquired equipment such as:

  • Analytical Instruments: HPLC, UPLC, TOC, ICP, KF

  • Thermal Equipment: Ovens, Freezers, Glassware Washers

  • Weighing Equipment: Balances

• Review and approve system specifications, user requirements, and other qualification documents.

• Perform periodic reviews and re-validations as needed.

• Support audits and inspections by providing documentation and responding to CSV-related queries.

Qualifications:

• Bachelor’s degree in Science (preferably in Chemistry), or a related field.

• Five (5) or more years of direct experience in CSV, with hands-on validation and qualification of laboratory equipment.

• Experience validating laboratory instruments such as HPLC, UPLC, TOC, and thermal equipment.

• Excellent documentation, analytical, and communication skills.

Work Methodology:

• 100% Work On-site
• Administrative Shift
• Professional Service Contract 
• Project Starting in June 2025