Indien solliciteer hier u verwijst naar een ongeldig webadres, is de vacature (hoogstwaarschijnlijk) inmiddels vervuld.
Attendeer FMF hierop
Site Validation Lead
Bergen op Zoom | Site Validation Lead | 1037954 | CSV | CAPA | GLP | GCP | GMP | Analytical | Result Oriented
Het bedrijf / The company
Philip Morris International is the leading international tobacco company, with six of the world"s top 15 international brands, including the number one cigarette brand worldwide. PMI"s products are sold in more than 180 markets. The fabric in Bergen op Zoom produces semi-finished products and the supply chain activities are organized for other PMI fabrics. Besides that, they create and produces the new IQOS products. This product has the potential to reduce the health damage in comparison with the regular tobacco products. You will join a dynamic, international and fast-paced work environment in a constantly evolving industry and will interact with different levels of experience and expertise across the company.
De functie / The role
As Validation Lead you are responsible for leading the validation and maintenance of systems during projects, as well as during the run and support phase. You ensure that the strategy of validation is defined and followed. Next to this, you will perform the QA reviews on documentation produced by the validation engineers and SMEs as per the QMS.
Also, you support the business partners in all GxP related decisions, including the compliant, safe, reliable and consistent operation of the computerized system and production equipment. You are the author of major validation documentation and the site validation plan. Besides that, you perform QA review of data governance documentation, which are produced prior to the projects to document data flow and conceptual data model, supporting risk analysis of the envisaged systems. Additionally, you advise the Project Manager and Service Manager on validation activities and workload to ensure proper planning and workforce mobilization to perform the activities. Lastly, you support non-conformity (NC) and corrective action/preventive action (CAPA) procedures.
Het profiel / Your profile
To succeed as Validation Engineer you have a master's degree in Technology, Engineering or Sciences. You have 5 - 10 years' experience in Computerized System Activities of validation activities and a background in pharmaceuticals, biotechnology, food or chemicals. Strong knowledge on GLP, GCP, GMP, 21 CFR Part11 and GAMP5 would be an asset. You are experienced and you have knowledge in Product Lifecycle Management, ERP and Manufacturing Execution System. You have strong communication skills, you are result oriented and you are a technology and process acumen. You have a fluent level of written and spoken English and preferable Dutch.
Het aanbod / The offer
You will join a dynamic, international and fast-paced work environment in a constantly evolving industry and will interact with different levels of experience and expertise across the company. Philip Morris offers you a fresh perspective. Here, you will never stop exploring and discovering. Philip Morris take on-the-job learning to another level, giving you every opportunity to develop your career and reach your full potential. This position will advance your experience with innovative technologies, services, and processes. Backed by a competitive salary and compensation package, you will work in a professional setting with clients and team members from all over the world.
Reactie / Reaction
If you are interested in the position of Site Validation Lead, click 'apply now' to forward an up-to-date copy of your CV, or call us now. If this job is not quite right for you, but you are looking for a new position, please contact us for a confidential discussion on your career.