Validation Engineer I

Our Work MattersAt Kindeva we make products that save lives ensuring better health and well-being for patients around the Impact You Will MakeAs a Validation Engineer you will play a critical role in ensuring our pharmaceutical manufacturing systems and processes meet rigorous regulatory and quality standards. You will lead and execute validation activitiesincluding equipment utilities facilities and process validationsto ensure our operations remain compliant and inspection-ready. Your expertise in cGMP risk-based validation and technical writing will directly impact the safety efficacy and consistency of the drug products we deliver. This is a highly visible hands-on role ideal for a detail-oriented professional passionate about quality and continuous improvement in a dynamic fast-paced environmentResponsibilities:Validation Strategy & ExecutionDevelop execute and maintain validation protocols and reports (IQ OQ PQ) for equipment utilities and manufacturing commissioning and qualification (C&Q) activities for new equipment and facilities ensuring compliance with FDA EU and global regulatory and review validation lifecycle documentation including plans protocols deviations and final with Engineering Manufacturing Quality and Regulatory Affairs to ensure effective cross-functional validation planning and periodic reviews and revalidation activities in accordance with lifecycle & Risk ManagementLead risk assessments (FMEA gap assessments) to determine validation strategy and appropriate testing validation input during change control deviation investigations and CAPA data integrity and good documentation practices in all validation as subject matter expert (SME) during internal and external audits and ImprovementEvaluate validation program effectiveness and recommend process improvements to enhance compliance efficiency and current with industry best practices and evolving regulatory guidance to ensure validation activities remain aligned with :Bachelors degree and a minimum of 2 years of related experience; or an advanced degree without experience; or equivalent work experience with a strong maintenance/engineering background or maintenance/engineering background or GxPExperience in developing and executing validation documentation (IQ/OQ/PQ protocols reports).Strong organizational communication and technical writing to collaborate cross-functionally and manage multiple priorities in a deadline-driven Qualifications:Familiarity with validation of automated systems and computerized system validation (CSV).Demonstrated knowledge of FDA EU and ICH regulatory requirements including 21 CFR Part 11 and Annex with nasal or respiratory drug delivery systems aseptic manufacturing or cleanroom knowledge of validation tools and systems (e.g. TrackWise ValGenesis Veeva).Lean Six Sigma or other continuous improvement training/certifications.#LI-Onsite