Validation Lead Crespellano, Italy Life Sciences

  • Crespellano
  • Philip Morris International
Validation Lead - Philip Morris Manufacturing & Technology Bologna Be a part of a revolutionary change: At PMI, we’ve chosen to do something incredible. We’re totally transforming our business, and building our future on smoke-free products with the power to deliver a smoke-free future worldwide. With huge change, comes huge opportunity. So, wherever you join us, you’ll enjoy the freedom to dream up and deliver better, brighter solutions and the space to move your career forward in endlessly different directions. Wherever you join our crucial 47,000-strong Operations team, you’ll have the opportunity to make an impact. PMI’s shift from selling cigarettes to our new smoke-free products has changed the way we work. New products bring new challenges - in the way we source and buy raw materials, in the way we engineer and manufacture, and in our supply chain planning. Your ‘day to day’: As a Validation Lead, you will lead PMI’s computerized system validation project approach and establish the validation strategy of computerized systems, including assessment and delivery of all validation deliverables. You ensure validation maintenance of GxP systems within your defined scope. You will also ensure the training of project team members and users of the system in the context of computerized systems validation and data integrity. This position will be based in Crespellano, Bologna. Specific responsibilities include: - Define, document and maintain the risk assessments for implementation of new systems and changes to existing GxP systems to support a risk based validation approach - Establish validation plans (including CSV Strategy) & validation reports of different projects - Perform QA Review of validation deliverables - Manage QA Review of Data governance documentation - Participate in the development and improvement of QMS procedures and practices for data integrity and CSV - Advise project managers and IS system service managers on validation activities in a timely manner - Train and coach on the validation and DI strategy as well as practices related to CSV and DI - Support affiliates for the validation of manufacturing core standard systems. Requirements & Skills: - University degree in Engineering or Science or equivalent - Information System and business experience would be an asset - Solid understanding of regulated life sciences industry processes (deep knowledge of CFR21 Part 11, Annex 11, GAMP5, etc.) from early research to industrial manufacturing (process mapping, data governance and architecture, traceability). - Proven CSV experience (5+ years) in a regulated environment, such as Life Sciences - At least 2+ years’ experience leading validation of GxP systems in a regulated life sciences industry - Experience in writing and reviewing validation deliverables related to CSV of GxP systems - Strong problem solving, solid communication and interpersonal abilities as well as proven leadership and organizational savvy - Excellent communication skills and fluency in English Employment Type: Permanent Relocation package offered What we offer: Our success depends on the men and women who come to work every single day with a sense of purpose and an appetite for progress. Join PMI and you too can: - Seize the freedom to define your future and ours. We’ll empower you to take risks, experiment and explore. - Be part of an inclusive, diverse culture, where everyone’s contribution is respected; collaborate with some of the world’s best people and feel like you belong. - Pursue your ambitions and develop your skills with a global business - our staggering size and scale provides endless opportunities to progress. - Take pride in delivering our promise to society: to deliver a smoke-free future worldwide. Philip Morris Manufacturing & Technology Bologna (PM MTB): PM MTB is Philip Morris International’s Center of excellence, worldwide recognized for prototyping, mass-volume production and employees’ training on smoke-free products. PM MTB employs more than 1000 employees and its production site of Crespellano is one of the most advanced manufacturing venues in Italy for technology innovation, competencies development and talent recognition. In 2019, Philip Morris Manufacturing & Technology Bologna has been awarded as Top Employer for the sixth year in a row. In the same year, was also granted the Equal Salary Certification certificate by the homonymous foundation to certify that men and women are paid equally for equivalent work. Bring us your curiosity and a desire to challenge the everyday and we’ll give you lots of responsibility. You’ll help us improve, inject innovation and create new ways of working. You’ll be solving supply chain problems that span the whole world: a smoke-free world.