Pacific Biosciences is looking for a candidate to lead the Process Validation activities. He/she will be responsible for developing related processes and methodologies. The candidate will work closely with the R&D and Manufacturing staff to ensure process validation requirements are met.
• Manage the development and execution of the process validation activities.
• Develop and implement strategies for equipment IQ/OQ/PQ, test method validation, and spreadsheet validation.
• Ensure the validation program meets requirements for in vitro diagnostics products.
• Perform risk assessments in conjunction with Quality and Operations subject matter experts.
• Provide updates to the Management team on process validation activities.
• Provide training to staff involved with the process validation activities.