Process Validation Engineer - Pharmaceutical

Job Title: Senior Process Validation Engineer – Pharmaceutical Experience: 5-8 Years Industry: Pharmaceutical / Biopharmaceutical Department: Manufacturing Science & Technology / Validation Employment Type: Full-Time Job Summary We are looking for a highly experienced Process Validation Engineer to lead validation activities for pharmaceutical manufacturing processes. The candidate will be responsible for Process Performance Qualification (PPQ), cleaning validation, process design, and continuous process monitoring to ensure regulatory compliance and consistent product quality. The ideal candidate will have strong experience in process validation lifecycle management and regulatory requirements within the pharmaceutical industry. Key Responsibilities • Process Validation • Plan, execute, and document Process Performance Qualification (PPQ) • studies. • Develop and review process validation protocols and reports. • Ensure validated processes meet regulatory and internal quality standards. • Cleaning Validation • Develop and implement cleaning validation strategies for manufacturing • equipment. • Prepare cleaning validation protocols, sampling plans, and reports. • Ensure compliance with regulatory expectations. • Continuous Process Monitoring • Implement continued process verification (CPV) programs. • Monitor process performance and analyze trends. • Support investigations and corrective actions for process deviations. • Process Design & Improvement • Support process design, scale-up, and technology transfer activities. • Work with cross-functional teams including Manufacturing, QA, MSAT, and • R&D. • Identify opportunities for process optimization and efficiency improvements. Compliance & Documentation • Validation protocols and reports • Prepare and maintain validation documentation including: • Risk assessments • Process validation master plans • Ensure compliance with cGMP, FDA, EMA, and ICH regulatory requirements. • Participate in internal and external audits. Required Qualifications • Bachelor’s or master’s degree in chemical engineering, Pharmaceutical • Engineering, Biotechnology, or related field. • 10–15 years of experience in pharmaceutical process validation. • Strong experience in PPQ, process validation lifecycle, and cleaning • validation. • Knowledge of cGMP, regulatory guidelines, and validation standard • Preferred Skills • Experience in continuous process monitoring / CPV. • Experience supporting regulatory inspections (USFDA / EMA / MHRA). • Familiarity with risk management tools such as FMEA and Quality Risk • Management. • Strong analytical, documentation, and communication skills.