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Automation & Validation Engineer

Date: Nov 16, 2021

Location: Santhia, IT, 0000

Company: Teva Pharmaceuticals

Who we are

 

Teva, leader in the sector of equivalent drugs and with a differentiated business that also includes specialized drugs, OTC and the production and marketing of APIs (pharmaceutical active ingredients), has been present in Italy for over 25 years with a commercial branch for the distribution of drugs and different production sites.
Our mission is simple: improve the wellbeing of patients, we care about them and about our colleagues, creating a respectful, diverse and inclusive working environment.
Teva improves health and contributes to people’s wellbeing each and every day, for this we are focused in everything we do by acting with integrity and maintaining the highest standards of quality, ethics and compliance
We all work for one company, Teva and we work together to achieve a common goal.
 

Reports to

 

Site Engineering Head

Main responsibilities

 

-Project Business analysis (Value Engineering) in order to evaluate feasibility of the project, alternative solutions, process impact and return on investment using Six Sigma and other Operational Excellence approach (GreenBelt Certification).
-Management of all the project phases from Concept and User Requirements (agreed with the stakeholder) till the commissioning and qualification phases (IQ/OQ/PQ) in conformity with EU GMP.
-Lead vendor audits and selection teams in order to recommend proper vendor/project matches for related systems (issue of Request For Proposal and Statement of Work) in accordance with procurement process.
-Work directly with the vendors or through outside engineering firms, to guide and oversee systems design for facilities.
-Development of estimates, track cost and schedule.
-Management of project Design Change with consequent impact analysis (cost, timing, safety, GMP).
-Automation System Administrator responsible for automation systems anomalies management, maintenance and validation (Configuration Management, Performance Monitoring, Security and Situational Operation).
-Manage all aspects of multiple related projects to ensure the overall program is aligned to and directly supports the achievement of strategic objectives.
-Work creatively and analytically in a problem-solving environment demonstrating teamwork, innovation and excellence.
-Defines the User Requirements and translate them into the project documents: P&LD, Lay-out, Data Sheet, Mechanical and electro-instrumental Work requisitions.
-Prepare estimates and detailed project plan for all phases of the project.
-Aligns offers from a technical point of view and arranges them financially, to allow the Purchasing department to proceed with the commercial negotiations.
-Defines and keeps under control the GANTT of the assigned projects, ensuring that deadlines are met in line with quality requirements.
-Guarantees full compliance with Safety and Quality standards in collaboration with the HSE and QA departments.
-Delta V DCS programming and configuration for new process plants implementation (Reactors, Filter Dryers, Vacuum Pumps, Thin Film Evaporators) DCS System Validation and Instruments calibration assessmentand management for FDA Inspection -- Coordinates the start-up and qualification activities of new systems and equipment.
-Finalize Commissioning, Qualification and Validation (CQV) strategy and execution plans for all site activities.
-Being the point of contact for both Teva and the Client for all CQV related matter.
-Actively work with site Teva safety team to ensure that C&Q operations are executed in safe manner.
-Be accountable for schedule, costs and customer quality expectations.
-Coordinate commissioning and qualification engineers, personnel provided by contractors as well personnel from vendors of complex equipment / packages.
-Support the finalization of the necessary documentation / protocols to be used during site activities.

 

Requirement

 

•Quality Management System knowledge (GMP, GDP, Data Integrity) and duly application in all activities performed.
•A thorough and working knowledge of Good Manufacturing Practice (GMP), GCPs, GLPs, GAMP and Part 11 compliance as they relate to qualification of systems and validation of processes.
•Significant experience in Automation and Control Engineering Discipline.
•Up to date knowledge / experience of legacy and modern PLC and SCADA systems.
•Knowledge of modern automation and control applications, tools, methodologies, or equal training / experience.
•Knowledge of Environment, Health and Safety principles and applicable main EHS local regulations.
•Full compliance with TEVA Ethic Code and Values.

Department

Engineering

Location

 

Santhià site, from Monday to Friday

Teva’s Equal Employment Opportunity Commitment

 

At Teva, we pride ourselves on being a company where we can all thrive, and where everyone feels comfortable being their true self.
Diversity and inclusion sits at the heart of everything we do. By valuing difference, we can be a better employer for our colleagues, and provide a better service for our customers and patients. That’s why we’re constantly looking for ways in which we can learn from each other, embrace what makes us unique and contribute to a fairer society free from discrimination and prejudice.