The Processes Analyst will be responsible for reviewing, designing, standardizing, and continuously improving workflows across laboratory and supporting operations.

The role will analyze existing processes, identify gaps, risks, and inefficiencies, and develop clear, controlled workflows that ensure consistency, traceability, compliance, and operational effectiveness.

The ideal candidate will have extensive experience within regulated healthcare or laboratory environments, with strong expertise in process design, controlled documentation, risk assessment, and continuous improvement.

Key Responsibilities

• Review and map end-to-end laboratory and operational processes, including process steps, responsibilities, handoffs, decision points, and controls.

• Design and optimize workflows to improve efficiency, consistency, traceability, and process control.

• Identify process gaps, bottlenecks, control weaknesses, redundancies, and potential failure points.

• Ensure alignment between operational workflows and SOPs, procedures, work instructions, forms, and controlled documents.

• Conduct process risk assessments and recommend appropriate controls and improvements.

• Support root-cause analysis, CAPA, deviations, and change-control activities where process improvements are required.

• Analyze recurring issues and audit findings to identify underlying process deficiencies.

• Establish standardized approaches for process mapping, documentation, and process review.

• Define relevant process indicators to monitor effectiveness and sustainability.

• Periodically review implemented workflows and recommend further improvements

Requirements

• Bachelor’s degree in Medical Laboratory Sciences, Pharmacy, Science, Biotechnology, Engineering, or a related technical discipline.

• Minimum 15 years of relevant experience, preferably within diagnostic laboratories, healthcare, pharmaceuticals, biotechnology, or another regulated environment.

• Strong experience in process mapping, workflow design, SOPs, controlled documentation, CAPA, risk assessment, root-cause analysis, and continuous improvement.

• Strong understanding of regulated operations, process controls, traceability, and documentation requirements.

• Familiarity with relevant laboratory accreditation and regulatory standards is highly preferred.

• Experience with Lean, Six Sigma, or similar process-improvement methodologies is an advantage.

• Proficiency with process-mapping tools such as Microsoft Visio, Lucidchart, or equivalent.

• Excellent written and verbal communication skills in English.

• Flexibility and willingness to travel internationally as required.