The QA Validation Engineer is responsible for coordinating, implementing, and maintaining the site validation program to ensure compliance with external regulatory requirements and industry best practices. The role involves oversight of validation activities for equipment, utilities, processes, and software, as well as participation in broader Quality Assurance initiatives.KEY RESPONSIBILITIES:Validation & Quality AssuranceCoordinate, direct, and actively participate in validation and QA activities for site equipment, utilities, processes, and software.Ensure compliance with FDA, European cGMP, and GAMP standards.Develop, maintain, and execute the Site Validation Master Plan and Project Validation Plans .Generate validation protocols, reports, and investigations to meet cGMP standards.Implement corrective actions as identified through validation investigations.Documentation & ComplianceCreate, review, and approve quality documents and test data.Manage validation, exception events, and change control processes.Maintain validation equipment records and ensure accurate tracking.Document all activities per cGMP requirements and update procedures to reflect current best practices.Training & Continuous ImprovementComplete all required training before performing tasks.Cross-train within the team and support onboarding of new team members.Participate in continuous improvement initiatives across manufacturing, quality, safety, and training systems.Communication & Team CollaborationCoordinate team activities for maximum efficiency.Maintain overall cGMP compliance in production areas.Communicate effectively with peers and management, escalating issues as needed.REQUIREMENTS:Essential QualificationsQualification and/or degree in engineering or a scientific discipline.Experience & Skills3+ years of validation or quality experience preferably in medical device plastics processing, moulding, or assembly operations, also pharmaceuticals/biotech.3+ years of knowledge in cGMP and regulatory requirements for the medical device/pharmaceutical industry.2+ years moulding and assembly experience and knowledge of automated lines.Strong communication (written and oral), presentation, and troubleshooting skills.Effective interpersonal and organizational skills.Ability to work independently and collaboratively in a team environment.Strong prioritization and multitasking abilities.Cognitive SkillsAbility to identify systems and processes requiring validation or QA support, ensuring timely documentation and resolution.Strong communication and motivation skills.Apply today