Job Information
Boehringer Ingelheim Senior Global Validation Manager - Automation in Biberach, Germany
The Position
As newest member of CBD Finance & Group Functions Global Facilities & Engineering (GFE) bundles Environment, Health & Safety (EHS), Security, Real Estate & Facility Management and Engineering globally, striving to serve Boehringer’s site network as strong infrastructure and business partner.
As part of the Global Engineering Compliance Team, the Global Senior Validation Manager Automation is accountable for the establishment and harmonization of validation standards, processes, and test strategy for computerized systems (Automation) across GFE and Boehringer Ingelheim Business Unit sites worldwide - always in alignment with international GxP, quality/compliance regulations and best engineering practices.
As Functional Lead of the regional/local Validation Managers Automation, you will be accountable for the implementation of automation system validation standards and processes within GFE organization worldwide.
This position can be filled in Ingelheim or Biberach.
Tasks & responsibilities
As Global Senior Validation Manager, you will bring in your skills in quality management systems and computerized systems validation to ensure lean implementation and continues improvement of the CSV Standards for Automation across GFE worldwide.
By providing functional leadership, coordination and coaching to the team of regional/local Validation Managers Automation, you will ensure their training enables them to achieve the operational metrics within their areas of responsibility and succeed in their roles.
You will be responsible for the establishment of centralized validation service and developing the appropriate organizational structure, resource plans and culture to support the business objectives.
Collaborating closely with global/regional/local GFE Automation Units, local and global Quality, IT, and the Business, you will develop the validation and test strategy, ensure cost-efficient implementation, and set the standards for Automation Systems.
You will drive continuous improvement to CSV Standards, processes, and capabilities, enhancing overall quality, compliance, and efficiency.
Based on the business processes involved, you will review the risk concerning computerized systems compliance and data integrity and propose solutions to mitigate the risks.
Requirements
Diploma or master’s degree (MBA, MSC) with major focus on automation, IT, engineering, sciences, Pharmaceuticals and/or Biotechnology or equivalent and longstanding professional experience in regulations and processes
In-depth knowledge of GxP regulations, CSV&C, and quality regulations/guidelines (e.g., EMA/Europe, FDA/USA, Anvisa/Brazil, CFDA/China, ICH, WHO) and in data integrity
Deep understanding of Engineering and IT trends and technologies with the experience how to bring and establish innovations into the business
Project Management skills in a complex international environment of multiple projects
Effective team player and ability to work in a rapidly changing environment
Proficient communication skills in German and English (verbal and written)
Ready to contact us?
If you have any questions about the job posting or process - please contact our HR Direct Team, Tel: +49 (0) 6132 77-3330 or per mail: hr.de@boehringer-ingelheim.com
Recruitment process:
Step 1: Online application - application deadline is May 29th 2024
Step 2: Virtual meeting beginning of June
Step 3: On-site interviews mid of June
Discover our Biberach site: xplorebiberach.com (https://careers.boehringer-ingelheim.com/biberach/)
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.