Are you passionate about PMI’s future, its culture change being the success driver for the transformation and experiences people go through every day in PMI? Do you look for ways to grow in your job?
If you want to challenge yourself, working in a dynamic & international environment, then apply now! We are currently looking for a:
VALIDATION LEAD (CSV) - Manufacturing
PMI has always been a leading company in the sector, but the time of transformation we are currently experiencing is quite exciting and is unprecedented. We are facing one of the greatest transformations in the history of fast-moving consumer goods, and the creation of a vision of a smoke-free future requires enormous courage, resourcefulness and motivation.
As Validation Lead (CSV) you will be part of our Information Systems (IS) Quality - Manufacturing department for Philip Morris Manufacturing & Technology Bologna S.p.A.. and will be reporting to the IS Quality Manager - Manufacturing. The position will be based in Bologna.
In your role, you will lead the validation of RRP computerized systems during project as well as run and support phase.
A key responsibility will be ensure the strategy of validation is defined and followed. In this position, you will perform the QA reviews on documentation produced by the validation engineers and SMEs as per the QMS.
Finally, you will support the business partners in all GxP related decisions, including the compliant, safe, reliable and consistent operation of the computerized system.
Specific responsibilities include:
- Define and lead the validation strategy of the systems for which she/he is accountable for.
- Set up, document and maintain the risk assessments (for projects and operations changes) of new and existing system to support risk based validation approach.
- Author major validation documentation (site validation master plan, validation plan, validation report, etc.) of projects for which he is accountable for.
- Perform QA review of documentation produced to support the validation of the systems.
- Participate in the development and improvement of QMS procedures and practices for CSV and DI for the area of responsibility.
- Advice project manager and service manager for validation activities and workload to ensure proper planning and workforce mobilization to perform the activities.
- Train and coach business partners on CSV and DI practices. Advice the business system owner on the fit for purpose of the system and provide input to release the system for use by the business.
- Perform QA review of data governance documentation which are produced prior the projects to document data flow and conceptual data model supporting risk analysis of the envisaged systems.
Requirements & Skills:
• University degree in Technology / Science / Engineering or equivalent.
• At least 5-10 years of experience in computerized system validation.
• Desirable IS and business experience in pharma industry.
• Strong knowledge on GLP, GCP, GMP, 21 CFR Part11 and GAMP5 would be an asset.
• Experience in the CSV for the area Manufacturing Systems and Process equipment.
• Extensive experience in process control systems validation.
• Experience in SCADA systems, Process instrumentation and vision systems would be beneficial
• Strong communication, negotiation, ability to coach, technology & business process acumen, deal with ambiguity, managerial courage, result oriented, project management
• Fluent in English both written and spoken and French is desirable.
Grade level from: 10 -11
Recruiter: Larissa Hirata
Employment Type: Local to local
Relocation package offered
WHAT WE OFFER
Our company offers you a new and fresh scientific perspective. Here, you will never stop exploring and discovering:
competitive wage conditions and the chance at potentially unlimited growth, thanks to performance monitoring systems that merge the talents of persons with their professional aspirations and allow for a constant growth of different proficiencies.
JOIN A GLOBAL MARKET LEADER
We are a leading international tobacco company engaged in the manufacture and sale of cigarettes and other nicotine-containing products in markets outside the United States of America. We are building our future on smoke-free products that are a much better consumer choice than continuing to smoke cigarettes. Through multidisciplinary capabilities in product development, state-of-the-art facilities and scientific substantiation, we aim to ensure that our smoke-free products meet adult consumer preferences and rigorous regulatory requirements. Our vision is that these products ultimately replace cigarettes to the benefit of adult smokers, society, our company and our shareholders. For more information, see our PMI and PMI Science websites.
Philip Morris Manufacturing & Technology Bologna is Philip Morris International's first center for personnel training and prototyping, industrialization, and large-scale production of potentially reduced risk products (RRPs).