Senior Process Validation Engineer

• Lead and execute Commissioning, Qualification, and Validation (CQV) activities in a Good Manufacturing Practice (GMP)-regulated manufacturing environment.
• Support development, characterisation, optimisation, and validation of automated and semi-automated assembly and packaging processes.
• Work hands-on with manufacturing and packaging equipment to troubleshoot process and equipment issues.
• Develop and execute qualification and validation protocols, including IQ/OQ/PQ and applicable process validation activities.
• Author validation plans, protocols, reports, summary reports, and other technical documentation.
• Perform statistical analysis using Minitab to support process characterisation and validation.
• Conduct process capability studies, Cp/Cpk analysis, MSA/Gage R&R, hypothesis testing, regression analysis, and DOE.
• Evaluate critical process parameters and process performance using data-driven statistical methodologies.
• Identify opportunities for process optimisation and continuous improvement.
• Lead deviation investigations, root-cause analysis, and CAPA-related activities.
• Support manufacturing investigations and provide real-time technical troubleshooting on the floor.
• Review and analyse qualification/validation data against established acceptance criteria.
• Support development and maintenance of validation plans, validation master plans, and validation summary reports.
• Work with Quality, Manufacturing, Engineering, R&D, and other cross-functional teams to support successful commercialisation and GMP operations.
• Utilise electronic quality/document management systems such as KNEAT, Veeva, Track Wise, or similar platforms.
• Serve as a technical SME for combination products, device assembly technologies, packaging processes, and GMP manufacturing operations.
• Independently make sound technical decisions during night-shift manufacturing activities with limited supervision.
• Participate in weekday and weekend night-shift activities based on manufacturing schedules.

Required Qualifications:

• Bachelor's degree in engineering, life sciences, or a related technical discipline.
• Strong experience in CQV, validation, process engineering, or process development within a GMP-regulated pharmaceutical, biotechnology, medical device, or combination-product environment.
• Hands-on experience with packaging equipment, combination products, device assembly, or automated/semi-automated manufacturing processes.
• Demonstrated ability to author and execute qualification and validation protocols and reports.
• Strong hands-on proficiency with Minitab.
• Demonstrated experience with:
• DOE / Design of Experiments
• Process capability analysis
• Cp/Cpk
• MSA / Gage R&R
• Hypothesis testing
• Regression analysis
• Statistical process analysis
• Experience with process characterization, optimization, and process performance monitoring.
• Experience with deviations, investigations, root-cause analysis, and continuous improvement.
• Strong understanding of GMP and validation principles.
• Excellent technical writing, documentation, and communication skills.
• Ability to work independently in a fast-paced manufacturing environment and make sound technical decisions with limited oversight.
• Willingness and ability to work night shifts, including weekends when required.

Preferred Qualifications:

• Experience with KNEAT, Veeva, Track Wise, or similar electronic quality systems.
• Experience with combination products or drug-device manufacturing.
• Experience with automated assembly and packaging equipment.
• Experience supporting commercial manufacturing and product/process commercialisation.
• Experience with statistical process control and Six Sigma methodologies.
• Experience developing and maintaining validation master plans and validation summary reports.