**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.
Division
Operations
Business Unit
Innovative Medicines
Location
Spain
Site
Zaragoza
Company / Legal Entity
ES45 (FCRS = ES045) AAA Ibérica S.L.U.
Functional Area
Technical Operations
Job Type
Full time
Employment Type
Regular
Shift Work
No