Engineering Expert Pharmaceutical Equipment
Job ID : REQ-10030151
Summary
Guarantee the operation in compliance with all the pharmaceutical and general equipment and systems present in the Saluggia site (intended GMP compliance, normative and standard compliance, eCompliance) to satisfy necessary requirements of pharmaceutical processes and safety requirements, with particular attention to the Aseptic Processes.
About the Role
Major Accountabilities
* Guarantee the correct operation of the equipment, systems, and plants present in the production site through the coordination of all technical activities carried out by internal and external resources.
* Coordinate technical activities on the equipment / systems as improvement projects and upgrade projects.
* Support production activities by participating in multi-department workshops and projects.
* Guarantee Aseptic process compliance (by equipment upgrade) and Aseptic Process improvement.
* Collaborate with MS&T and Production departments to better understand their needs and processes for systems compliance, efficiency, and reliability (evaluating needs for upgrade or substitution).
* Accountability and / or responsibility for the GMP documentation both external and internal.
* Improve the qualification, validation, and other GMP / technical documentation adapting it to corporate standards.
* Execute qualification (and sometimes validation) activities or coordinate external resources in execution under own accountability.
* Support the process of Continuous Improvement and Compliance for aseptic processes.
* Guarantee the safety of internal and external resources working on the equipment, in accordance with applicable normative and corporate procedures (through the implementation of preventive measures).
* Participate in technical investigations on GMP deviations on the site production systems and processes.
Key Performance Indicators
* Active collaboration in multi-department teams to guarantee compliance of the production processes (by equipment and systems compliance).
* Execution of the Production planning (by efficiency and reliability of the equipment).
* GMP compliance and eCompliance of the equipment and systems (by respecting maintenance, calibration, and requalification plans).
* HSE performance indicators (safety as principal).
* Qualification and Validation of new equipment or systems respecting scheduling and budget of the Investment projects.
* Requalification and Revalidation of existing equipment / systems up to Validation Activity Schedule (yearly qualification / validation plan) – on time.
* Execution of the Site Quality Plan.
Job Dimensions
Subordinate Functions : None
Number of Associates : Direct : 0; Indirect : 2-3
Financial responsibility (where appropriate) : N / A
Impact on the organization (where appropriate) : High.
Ideal Background
Education : Bachelor Degree In Engineering (5 years) – preferably electrical or mechanical.
Languages : Fluent English spoken and written. Basic Knowledge of the Pharmaceutical and Technical terminology in English.
Skills (and Experiences) desired :
* 5-year Direct experience in Pharmaceutical companies or Consultant Companies for Pharmaceutical industry.
* Direct experience in managing pharmaceutical equipment (maintenance, calibration, requalification) with particular attention to Aseptic processes (sterilization, depyrogenation, freeze drying, aseptic filling, WFI loops, …).
* Direct experience and knowledge of GMP documentation (Risk Assessment, Change Request / Management, Root cause analysis, Statistical analysis of production and performance indicators).
* Direct experience in preparation of the GMP documentation for pharmaceutical equipment.
* Direct Experience in handling projects for upgrade or substitution of existing pharmaceutical equipment.
* Direct experience in management (definition, follow-up) of budget for equipment investments.
* Direct experience in management and coordination of external contractors and consultants.
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Functional Area : Technical Operations
Job Type : Full time
Employment Type : Regular
Shift Work : No
Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
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Engineering Expert Pharmaceutical Equipment • alessandria, Italia
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