Company Description NovintiX is a leader in engineering services, dedicated to innovating and transforming industries like Medical Devices, Aerospace, Automotive, Consumer Electronics, and Industrial Equipment. With cutting-edge expertise in areas such as Product Engineering, Digital Solutions, Supply Chain Management, and Quality Compliance, we empower meaningful solutions that drive growth and excellence. Guided by a forward-thinking vision, NovintiX fosters innovation while prioritizing the success of both clients and employees. Our mission to provide best-in-class services underscores a commitment to shaping a sustainable, technology-driven future Job Title: Senior Process Validation Engineer Job Location: Ireland, Netherland Industry: Pharmaceutical Job Description: This role focuses on the end-to-end management of process validation lifecycle activities, ensuring robust manufacturing processes that meet regulatory and quality requirements. Proactively manages validation activities including PPQ, CPV, and cleaning validation, ensuring processes consistently meet defined performance criteria. Collaborates with internal stakeholders (MSAT, QA, QC, Manufacturing, Engineering) to ensure alignment with process control strategy and compliance expectations. Participates in process design, scale-up, technology transfer, and lifecycle management, ensuring sustained process performance and continuous improvement. Qualification: Education level: Bachelors or masters degree in Pharmaceutical Engineering, Biotechnology, or related field 8+ years of experience in pharmaceutical process validation / MSAT / technical operations Strong experience in PPQ, process validation lifecycle, cleaning validation, and CPV Working knowledge of commercial manufacturing processes and validation requirements Good communication skills; strong analytical and problem-solving capability Proven ability to work in cross-functional and regulated environments In-depth understanding of cGMP, FDA, EMA, and ICH guidelines Job Responsibilities: Lead PPQ planning, execution, and reporting for commercial manufacturing processes Develop, review, and approve validation protocols, reports, and associated documentation Ensure validation activities are aligned with CPPs, CQAs, and process control strategy Coordinate cross-functional teams to support batch execution, sampling, and data collection Develop and implement cleaning validation strategies, including protocols, sampling plans, and reports Ensure compliance of cleaning processes with regulatory and internal standards Establish and maintain Continued Process Verification (CPV) programs, including monitoring and trending Analyse process performance data and support investigations, deviations, and CAPA activities Support process lifecycle activities, revalidation, and change control Contribute to process improvements, optimization, and efficiency initiatives Collaborate with MSAT, Manufacturing, QA, QC, Engineering, and R&D teams for validation and process-related activities Support technology transfer and scale-up activities to ensure process robustness Prepare and maintain validation documentation including protocols, reports, risk assessments, and VMP inputs Ensure compliance with cGMP, FDA, EMA, and ICH regulatory requirements Participate in internal audits and regulatory inspections, providing validation subject matter expertise Drive effective deviation management, root cause analysis, and corrective actions related to process validation Support implementation of risk management practices in validation activities Complete other tasks assigned by Supervisor / Manager Skills Proficient in MS Office Suite (Word, Excel, PowerPoint, etc.) Strong knowledge of cGMP, FDA, EMA, ICH Q8/Q9/Q10 guidelines Solid understanding of process validation lifecycle and regulatory expectations Experience with CPV, data trending, and statistical analysis tools Knowledge of Quality Risk Management Experience in deviation management, CAPA, and root cause analysis Familiarity with QMS/DMS systems (e.g., Veeva Vault, Strong analytical, documentation, and communication skills Continuous improvement mindset and ability to drive process optimization initiatives If interested, please apply by emailing your resume to Skills: PPQ CPV Cleaning Validation cGMP FDA EMA ICH Q8/Q9/Q10 Benefits: health insurance