Position: Junior Validation Specialist
Reporting to: Senior Engineering Manager
Location: Leiden, Netherlands
Mentor is a leading supplier of breast implants in the global aesthetic market. The company develops, manufactures, and markets innovative, science-based products for surgical and non-surgical medical procedures that allow breast surgery patients to improve their quality of life. The company is focused on two strategic areas: breast reconstruction and breast augmentation. For over 20 years, more than 5 million women have chosen MENTOR® Breast Implants.
About J&J :
For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.
We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.
That is why we in Leiden are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.
Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”
Under the direction of the Sr. Supervisor Maintenance, will be responsible for supporting the validation lead in executing the requalification and revalidation of equipment within the manufacturing process. Support the engineering team to ensure compliant status of manufacturing equipment utilized for production and laboratory testing equipment. Support the calibration team ensuring calibration compliance of equipment as well. Role interfaces directly with other Mentor functional groups to ensure that goals/objectives are met within GMP/ISO compliance and product design changes are addressed appropriately.
The responsibilities & the impact YOU will have:
Under (e.g. limited supervision, general direction, etc.) and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
· General Duties:
o Responsible for communicating business related issues or opportunities to next management level.
o Follows Standard Operating Procedures (SOP), Good Manufacturing Practices (GMPs), Company Policies and Federal, State and Local Government Regulations.
o Perform and support other duties assigned as needed and requested within the organizational framework.
· Technical Duties:
o Writes, executes, and reviews validation protocols and reports, including analyses of data.
o Execution of validation studies.
o Execution of calibrations according to planning.
o Coordination of Validation and Qualification activities.
o Calibration and qualification of new equipment and input in calibration system.
o Support with NCR/CAPA action execution for Validation and Engineering related actions.
o Analyzing and resolving of calibration or qualification related issues with equipment and tooling.
o Participates in projects involving other departments and activities.
We would love to hear from YOU, if you have the following requirements:
· Secondary Vocational education.
· Preferably bachelor’s degree in engineering.
· Up to 2 – 4 years of experience in validation or calibration in a medical devices environment is preferred.
· Project management skills and training.
· Basic computer skills and use of software application(s).
MS Office, MS project Management, Power Point, Word, Excel, Outlook
(Maintenance Management System- Maximo.
Quality Analysis softwares:- , Minitab.
Familiarity with Dashboarding techniques.
· Regular organizational, interpersonal, oral, and written communication skills.
· Ability to prioritize multiple commitments and problem-solving ability.
· Ability to shift priorities according to changes in department/facility needs and be open to different ideas/approaches.