The Estee Lauder Companies Data Integrity Site Program Engineer (Lead) in Schwyz-Lachen, Switzerland
Data Integrity Site Program Engineer (Lead)
The primary purpose of this newly created position is to effectively lead the Data Integrity (DI) program across the Supply Chain function (Manufacturing/QA) for our Manufacturing site in Lachen/Switzerland. The job holder will work closely with the Global Data Integrity Technical Program lead to align on the DI strategy for the manufacturing site and for DI execution activities, but will report directly to the local Plant Manager with a matrix reporting relationship to the Plant Quality Lead.
The main job responsibilities will be:
Supporting the design of the corporate DI system as well as oversight across all GxP (Good Clinical/Manufacturing/Documentation practices) computerized systems.
Working across multiple business functions at the site level to rollout DI requirements and ensuring excellence in execution with the technical community of the Supply Chain organization and will provide visibility and management of priorities and risks and opportunities for DI related activities and elevated to leadership where appropriate.
Ensuring Data Integrity technical deliverables for Supply chain for their respective site with monthly updates.
Close collaboration with Corporate functions – Global R&D and Global QA – to ensure robust Standard Operating Procedures and Work Instructions are in place to ensure compliant GxP systems.
The process scope includes managing:
Requirements for purchasing, install and qualification of existing and new equipment and Introduction across the respective manufacturing site.
Maintenance and calibration of existing/new GxP computerized systems to ensure optimal performance.
Governance of process, access and documentation to ensure compliance
Support all validation activities and responsible for oversight of compliance records and supporting documentation.
You have a minimum of 5 years of relevant professional experience
You have experience in staff management with proven ability to manage and collaborate in a multi-location, multi-vendor environment with an emphasis on process documentation and training.
You must be an excellent team player with strong analytical skills, negotiating and communication skills.
You have strong program management skills including follow-up and organizational skills required.
You have the ability to use computer systems necessary to meet objectives including Microsoft Office, MS project, SAP
You are experienced in Supply Chain processes and systems in a Fortune 500 CPG company.
You are experienced in managing various laboratory equipment and systems in a highly dynamic corporate landscape.
You are experienced in writing Standard Operating Procedures and Work Instructions and other Quality System Documents.
You bring knowledge in:
GXP (Good Clinical/Manufacturing/Documentation practices)
FDA Validation and CFR 21 Part 11
Various software applications and SAP ERP are a plus
You are fluent in English (business proficiency) and German.
Primärer Standort Europa, Mittlerer Osten, Afrika-CH-Schwyz-Lachen
Organisation Estée Lauder Companies
Job Number: 194236