Role Summary:The CQV Engineer will be responsible for the commissioning, qualification, and validation of complex manufacturing equipment with a focus on Fillers, Isolators, and Lyophilizers. The successful candidate will ensure compliant integration and operation of these critical systems in support of sterile product manufacturing. The role requires close collaboration with engineering project teams, vendors, QA, and operations to achieve all project milestones and maintain regulatory compliance.Key ResponsibilitiesCommissioning & Start-up: Plan and execute commissioning activities for new and existing Fillers, Isolators, and Lyophilizers, including Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT), and system troubleshooting.Qualification Documentation: Develop, review, and execute the full CQV lifecycle (User Requirement Specifications, DQ, IQ, OQ, PQ) specific to filling, isolation, and lyophilization equipment.Process Validation: Support or lead protocols for media fill, aseptic process simulation, and lyophilization cycle development, including loading studies and process optimization.Documentation: Author, review, and approve protocols, summary reports, technical documentation, cycle development reports, and SOPs; ensure documentation is audit-ready.Risk & Data Analysis: Perform and review risk assessments and in-depth analysis of qualification and validation data, including temperature mapping, particle/bioburden testing, leak/pressure hold testing, and residual moisture analysis.Compliance Assurance: Ensure project activities comply with cGMP, EU Annex 1, FDA, ISO standards, and quality management system requirements.Issue Resolution: Collaborate with cross-functional teams to resolve technical issues, deviations, and change controls related to equipment or process.Training: Provide technical training and support to operations and maintenance staff on best practices for equipment operation, cleaning, and qualification protocols.Continuous Improvement: Identify and drive opportunities for process improvements, increased reliability, and enhanced compliance in filling, isolation, and lyophilization operations.Skills & Experience RequiredBachelor's degree in Engineering, Life Sciences, or a related discipline (or equivalent industrial experience).Minimum (X) years of CQV experience in GMP pharmaceutical/biotech manufacturing environments.Hands-on experience commissioning, qualifying, and validating at least one of the following: aseptic Fillers (liquid/powder), Isolators (restricted-access barriers), or Lyophilizers (freeze dryers).Proven experience authoring and executing qualification and validation protocols and lifecycle documents.Knowledge of aseptic processing requirements, EN/ISO standards (e.g., ISO 14644, EU Annex 1), and regulatory validation guidance (FDA, ICH Q9 & Q10).Familiarity with utility systems and automation interfaces typically used in filler, isolator, and lyo equipment.Strong troubleshooting, root cause analysis, and systematic problem-solving abilities.Excellent communication, planning, and organizational skills.