The RoleThe Quality Engineer will provide quality oversight to manufacturing and technical activities, ensuring compliance withGMP, regulatory, and internal quality standards, while supporting site projects and NPI activities.Key ResponsibilitiesProvide quality engineering support to manufacturing, validation, and technical teamsAct as Quality representative for New Product Introduction (NPI) projects, supporting tech transfer and process scale-upSupport preparation, review, and approval of GMP documentation (SOPs, protocols, reports)Lead and support deviations, CAPAs, change controls, and risk assessmentsSupport process validation, cleaning validation, and equipment qualification activitiesParticipate in internal, customer, and regulatory audits and inspectionsDrive continuous improvement initiatives to enhance product quality and complianceEnsure quality systems align with ICH, EU GMP, and FDA requirementsRequirementsDegree in Engineering, Science, or a related disciplineExperience in a Quality Engineering or Quality Assurance role within the pharmaceutical or biotech industryStrong working knowledge of GMP and quality systemsExperience supporting NPI, tech transfer, or process introduction is highly desirableFamiliarity with deviation management, CAPA, and change management systemsStrong problem-solving, communication, and stakeholder management skillsDesirableExperience with sterile manufacturing, biologics, or fill-finish operationsKnowledge of risk management tools (FMEA, Fishbone, 5 Whys)Experience working with cross-functional project teams