Validation Engineer

　　Date: Jan 19, 2024

　　Location:

　　Caronno Pertusella, Italy, 0000

　　Company: Teva Pharmaceuticals

　　Job Id: 53768

　　Who we are

　　Teva, world leader with over 40.000 employees, in the field of equivalent medicines, with a differentiated business that also includes specialist medicines, over-the-counter drugs and the production and marketing of APIs (active pharmaceutical ingredients), is present in Italy for over 25 years with a commercial branch and manufacturing sites.

　　Our mission is simple: improve the wellbeing of our patients.

　　We care about them and about our colleagues, creating a respectful, diverse and inclusive working environment, committing ourselves to maintaining high standards of quality, compliance and safety, always respecting our values:

　　Teva Code of conduct (https://www.tevapharm.com/globalassets/tevapharm-vision-files/teva_codeofconduct_12feb2019_final.pdf)

　　We all work for one company and we work together to achieve a common goal.

　　Main responsibilities and activities

　　In the Engineering Department we are looking for a brilliant profile reporting to the Site Engineering Head with the following responsibilities and activities for Caronno and Villanterio sites:

　　Defines and manage the equipment and utilities requalification plan.

　　Leads the qualification of new or modified equipment, utilities and computerized systems.

　　Manages and drive the suppliers in the qualification activities of the new or existing equipment.

　　Collaborates with the Engineering team and other departments like QA, MS&T, Production to develop validation master plans, standard operating procedures, and other GMP documents.

　　Collaborates with the Engineering team and other departments like QA, MS&T, Production to manage Deviations, CAPAs and Change Controls.

　　Analyzes and conduct risk assessments supporting the Engineering projects.

　　Analyzes and conduct risk assessments supporting the Maintenance activities.

　　Supports the Maintenance Manager to review the preventive maintenance plan based on the results of equipment qualification or the periodic annual review of equipment and utilities.

　　Assists in training operators or other staff on qualification protocols and standard operating procedures.

　　Participates in internal or external training programs to maintain the knowledge of qualification principles, industry trends, or best technologies.

　　Requirements

　　Main Requirements:

　　Priority system knowledge and management.

　　Quality Management System knowledge (GMP, GDP, Data Integrity) and duly application in all activities performed.

　　Knowledge of Environment, Health and Safety principles and applicable main EHS local regulations.

　　Full compliance with TEVA Ethic Code and Values.

　　Education:

　　Engineering Degree – preferably Chemical or equivalent technical degree.

　　Languages:

　　English and Italian (good level of proficiency).

　　Skills:

　　Objectives focused with excellent planning and organizational ability.

　　Good communication skills with attitude to work cross-functionally in a complex and variable environment.

　　Day-by-day high focus together with mid-long term view.

　　Good attitude to planning and prioritization in alignment with business and customer needs.

　　IT systems familiarity.

　　Experience:

　　3 years’ experience preferably within relevant industrial production environment.

　　3 – 5 years’ experience in Qualification and GMP Compliance area.

　　Quality Management System knowledge (GMP, GDP, Data Integrity) and duly application in all activities performed.

　　What we offer?

　　We try to take care of our employees, offering them small and large benefits. By way of example:

　　Ticket Restaurants for each working day

　　Working flexibility for Caregivers and parents

　　Recognition Program

　　Welfare Platform

　　Highly inclusive and multicultural working environment

　　Continuous learning and development programs (with full access to Linkedin Learning!)

　　Type of contract: long term contract

　　Location and working program

　　Caronno (VA), from Monday to Friday

　　Teva's commitment to equal opportunities

　　Teva is committed to equal opportunities in the world of work. Our global policy requires equal employment opportunities to be provided regardless of age, race, religion, health, identity or gender expression, or any other legally recognized status that is entitled to protection under applicable laws.

　　EOE including disability/veteran