As a Computer System Validation Lead Engineer, you will develop and enforce the Quality Systems for life-science industry projects.
You will be someone who is prepared to be the Quality 'voice', and who will support quality on projects as well as within the department.In This Role, Your Responsibilities Will Be:Ensure team is focused on User Requirements, co-ordinate project traceability and assist in reviewing project documentation (Functional Specification, Configuration Specification, Design Specification, test specifications).Develop Test Strategy and Test Plans with Lead Engineer.
Perform training at the start of test phases, to ensure testers (including customers) understand their responsibilities.
Support the team during test execution.
Collect evidence of performed test and prepare test report.
Keep track of deviations and their status.
Validate driven test documents.Review all the quality relevant documents (and at times help to prepare) and ensure good communication to project team.Train the project team in the pharma guidelines and enforce in their use.Assist in Project Quality Audits and support Quality Department to keep schedule and track of them.Who You Are:You are a great teammate, problem-solving, ambitious technical person, passionate about making an impact and always act with integrity.
You are aware of the opportunity to be an authority in our industry.For This Role, You Will Need:Technical education or bachelor's engineering degree.At least 2 years of proven successful experience in Life Science industry.Proficiency in Italian and English (verbal, reading and writing) is required.Willingness to travel up to 50% of the time.Preferred Qualifications that Set You Apart:Knowledge of ISO 9001 is a plus.Proactive and able to work effectively within a team.Ability to influence the culture of a project team or department to adopt and maintain good quality standards.Knowledge of current Pharmaceutical Industry Regulations and standards for Computerized System Validation would be a plus.Willingness to work on customer site.Ability to work within a complex matrix organization and collaborate across business units.Our Offer to You:At Emerson, we are committed to fostering a culture where every employee is valued and respected for their unique experiences and perspectives.
We believe a diverse and inclusive work environment contributes to the rich exchange of ideas and diversity of thoughts, that inspire innovation and brings the best solutions to our customers.
We're emphasizing a culture of togetherness - one that builds community, prioritizes collaboration and continuous improvement.Moreover, our global volunteer employee resource groups will empower you to connect with peers that share the same interest, promote diversity and inclusion and positively contribute to communities around us.We understand the importance of work-life balance and are dedicated to supporting our employees' personal and professional needs.
From competitive benefits plans and comprehensive medical care to equitable opportunities for growth and development, we strive to create a workplace that is supportive and rewarding.
Our work schedule aims at creating new levels of growth, building a stronger community and providing greater professional development for our employees.Make this great opportunity yours!
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