Job Title

Who are we? Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been delivering solutions in major projects for over a decade with an international team of 7,600 people across 5 continents and more than 60 countries. Our solutions focus on four business lines: Information System & Digital, Telecom, Life Sciences, and Engineering. Were focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success. At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and provide timely feedback. Here is what our recruitment process looks like: - Brief Call: A brief virtual/phone conversation to learn about you, understand your motivations, and ensure we have the right job fit. - Interviews: The average number of interviews is 3 (may vary by level). You will meet your line manager and others related to the future role. We discuss your experience, skills, and the position, and you will learn about Amaris, our culture, and career opportunities. - Case study: Depending on the position, a test may be requested (e.g., role play, technical assessment, or problem-solving scenario). - We adapt the process as needed to fit the candidate, while maintaining a strong candidate experience. We look forward to meeting you! Job description We are seeking an experienced Thermal Validation & CQV Engineer to lead and execute Commissioning, Qualification, and Validation (CQV) activities across facilities, utilities, systems, and equipment in a GMP-regulated environment. You will be responsible for developing and performing thermal validation for sterilization and decontamination systems, ensuring compliance, accuracy, and inspection readiness throughout the validation lifecycle. Key Responsibilities - Lead and execute CQV activities for facilities, utilities, and process equipment across routine operations and capital projects. - Author and review risk-based C&Q documentation: FCCA, RTM, DQ, CTP, IOQ/PQ, EM PQ, smoke studies, and thermal validation protocols (heat penetration, cycle development, ranking studies; moist heat, dry heat, VHP). - Plan and perform FAT/SAT, critical test plans, and CSV activities where applicable (equipment/automation interfaces). - Perform thermal validation using Kaye AVS v1.4+ (or equivalent): - Thermocouple preparation, calibration, and placement. - BI (Biological Indicator) handling and exposure. - Cycle execution, data capture, and analysis. - Cycle optimization and performance qualification. - Validate sterilization and decontamination systems, including: Autoclaves, isolators, tunnels, ovens, vial washers, SIP systems, biowaste and decontamination autoclaves, and sanitization systems. - Support annual validation programs: smoke studies, sterilizer/isolator/tunnel/oven/SIP requalification, and temperature mapping of controlled units. - Investigate and document deviations and non-conformances, perform root cause analysis, and generate inspection-ready validation reports. - Own documentation and scheduling, including change controls, SOPs/WIs, PM task lists, and regular reporting via Excel/PPT (Teams/Email). - Collaborate closely with Operations, MSAT, Automation, Engineering & Maintenance, and Quality teams to ensure GMP compliance and inspection readiness. - Promote continuous improvement and provide mentorship and guidance to junior validation staff. Tools & Platforms - Kaye AVS v1.4+ (or equivalent) for thermal validation and data acquisition. - Kneat (paperless validation) and Veeva Vault for documentation management. Profile Requirements Education - Bachelors degree in Engineering, Pharmaceutical Sciences, Microbiology, or a related discipline. Experience by Level - Consultant / Intermediate: 36 years of CQV/CSV/thermal validation experience in a GMP pharmaceutical or biotech environment. - Senior: 610+ years with protocol/report ownership and cross-functional leadership. - SME / Lead: 10+ years leading complex validation programs and supporting inspections. Technical Expertise - Strong hands-on experience with: - Thermal cycle development, heat penetration studies, and BI logistics. - Temperature mapping and smoke studies. - IOQ/PQ execution and requalification activities. - Solid understanding of FAT/SAT, risk-based validation, FCCA, RTM, and CSV principles. - Proficiency in Kaye AVS systems and familiarity with Kneat and/or Veeva Vault. - Strong knowledge of GMP/GLP/GDP/EHS and ALCOA+ data integrity standards. - Excellent skills in technical writing, data/statistical analysis, and problem-solving. Nice to Have - Expertise in VHP/depyrogenation and SIP/CIP qualification (complex/custom systems). - Experience with isolators, tunnels, vial washers, and biowaste systems. - Exposure to large capital projects and site-wide validation strategies. - Experience mentoring or upskilling junior engineers; continuous improvement mindset. Why choose us - An international community bringing together more than 110 different nationalities - An environment where trust is central: 70% of our leaders started their careers at the entry level - A strong training system with our internal Academy and more than 250 modules available - A dynamic work environment that frequently comes together for internal events (afterworks, team buildings, etc.) Amaris Consulting promotes equal opportunities. We are committed to bringing together people from diverse backgrounds and creating an inclusive work environment. In this regard, we welcome applications from all qualified individuals, regardless of sex, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics. #J-18808-Ljbffr