Qualifications

• Bachelor's degree in Engineering (Chemical, Biomedical, Mechanical, or equivalent) or a related scientific discipline.
• 3-5 years of validation experience in biopharmaceutical or pharmaceutical industries.
• In-depth knowledge of cGMP, ICH guidelines, and FDA regulations.
• Hands-on experience with autoclave validation and IQ, OQ, PQ processes.
• Strong understanding of quality systems including change control and CAPA.
• Excellent technical writing and communication skills.
• Ability to work independently and collaboratively in fast-paced settings.

Responsibilities

• Develop and execute validation protocols and reports for equipment, utilities, and facilities.
• Create and implement CQV deliverables for Sterilization programs, focusing on autoclave cycles.
• Perform risk assessments and develop validation strategies in line with regulatory guidelines.
• Coordinate validation activities across Manufacturing, Quality Assurance, Engineering, and R&D.
• Analyze validation data and recommend corrective and preventive actions (CAPAs).
• Prepare and present validation documentation to auditors.
• Support regulatory inspections and internal audits with validation expertise.

Benefits

• Relocation assistance available for eligible candidates and families.
• Office-first role with the flexibility to work remotely one day a week.
• Close, real-time collaboration to enhance work quality and safety standards.
• Opportunity to contribute to the continuous improvement of validation processes.