Validation Engineer

Description:

An exciting opportunity for an experienced Validation interested in a new challenge in a cGMP regulatory environment. The successful candidates will support several aspects of Validation.

Role Responsibilities

• Serve as validation representative for cross functional projects and represent the validation team at global technical forums
• Drive compliance of Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions, ensuring consideration of the impact on GMP and compliance and decisions made.
• Accountable for compliance via documentation completion, risk assessments, closing out corrective actions, participation in audits and inspections and proactively highlighting any issues around compliance
• Supporting regulatory audits and submissions as required.

Prefered Experience

• Equipment Periodic Validation
• Equipment Validation Lifecycle
• Project Management Skills/Qualification
• Filter Validation & Container Closure Validation
• Autoclave/SIP Sterilisation Validation
• Dry Heat Sterilisation
• Isolator Qualification
• Vial and Syringe Processing Technologies
• Temperature Mapping
• Cleaning Validation