**Summary**:The Commissioning & Qualification / Compliance EngineerTo manages the Projects Facility, Process, HVAC, Clean room and Utility Services Commissioning & Qualifications activities including developing the Protocols and execution of reports for manufacturing equipment. Responsible for handling multiple projects Commissioning & Qualifications activities considering end to end Project management. Will also be responsible for organizing, budgeting, scheduling, executing & monitoring the performance of project as per required timelines.**About the Role**:**Major Accountabilities**- Responsible for Preparation/execution/compiling of Facility, Process, HVAC, Clean room and Utility Services Commissioning & Qualifications activities Protocols/reports for the Pharmaceutical facilities which includes manufacturing facilities. Preparations of Commissioning & Qualifications Protocols/ Standard operating Procedures/ Work instructions.- Responsible for onsite support C&Q; activities by following ISPE/ASTM methodologies utilizing GDP, GEP, C&Q; Base line guides, GAMP 5 & cGMP Principles. In depth knowledge of Regulatory Guidelines- USFDA, MHRA, WHO, ISO, 21 CFR part 11 and other regulatory guidelines.- Planning, developing, execution, reporting of C&Q; Deliverables.- Prepare/ Review of Validation master plan, Validation plans, Validation Documents, Commissioning & Validation execution of Clean Room & HVAC Systems (Such as DQ, IQ, OQ & PQ) in Pharmaceutical Industries as per the required standards.- Preparations & execution of Pre-commissioning & Commissioning checklists for various systems including Facility & Process/Utility Equipments.- Preparation & execution of Facility, Utility & process equipment FAT/SAT/IOQ Protocols/Reports.- Improve and optimize based on requirements qualification activities and qualification activities, including modifying SOPs were required. Document periodic reviews for manufacturing equipment and utilities required onsite.- Maintain documentation package for qualification, periodic reviews on time in compliance.- Maintain procedures in compliance for Engineering department. Introduce and implement change when required following Quality Management System from Novartis.**Essential Requirements**:- Education: Degree in Mechanical/Chemical Engineering.- 8-10 years of experience in Pharmaceutical/ Chemical/ FMCG Industry.- Deep understanding of Project Commissioning & Qualification activities like Facility/HVAC/Clean room / Black & Clean Utility services/Process equipment within pharmaceutical industry.- Good Knowledge of Project management like - Project planning, Cost Management, Time Management, Construction management, Quality Management, Contract Administration, Safety Management & required Statutory approvals management.- Fluent in English and Spanish, written and spoken.**Commitment to Diversity and Inclusion**:Novartis is committed to building an outstanding, inclusive work environment and diverse teams' representative of the patients and communities we serve.DivisionOperationsBusiness UnitInnovative MedicinesLocationSpainSiteZaragozaCompany / Legal EntityES45 (FCRS = ES045) AAA Ibérica S.L.U.Functional AreaTechnical OperationsJob TypeFull timeEmployment TypeRegularShift WorkNo