Johnson & Johnson
Commissioning & Qualification Engineer
Duration: until Dec 2023
The position will report to the C&Q Manger and is in charge of Commissioning & Qualification (C&Q) activities for Technical Services department in order to ensure that:
Qualification/Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
Roles and Responsibilities
Qualification/Validation Master plans are up to date and established for all ongoing projects
Write/review Qualification/Validation plans, including but not limited to DQ, IQ, OQ, PQ plans/protocols and final reports for new or modified GMP utilities, facilities, and process equipment
Execution of DQ, IQ, OQ, PQ, including protocol deviations, investigation, and corrective action activities for new or modified GMP utilities, facilities, and process equipment
Plan and track execution of Commissioning & Qualification activities/documentation versus project(s) timeline
Prepare, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment, Master plans, qualification/validation documentation)
Coordinate and execute FAT/SAT, commissioning activities for new GMP systems in collaboration with internal and external partners
Coordination and oversight of external suppliers
How To Succeed
What We Look For In a Candidate
Bachelor/Master’s degree in technical or natural sciences
A minimum of 3 years of working experience within pharma company in C&Q/CQV equivalent position
Know-how of Qualification requirements according to cGMP regulations
Experience working with cross-department stakeholders
Know-how of quality assurance principles
Experience working in project teams and multiple projects in parallel
Experience working with ISPE baseline guide vol 3, vol 4 and vol 5 is a plus
Excellent communication skills, Analytical thinking and problem-solving ability
Business fluency in English, German language is a plus
This role offers a very competitive hourly rate. This contract will run for 9 months and will be reviewed for an extension.
You Are Welcome Here
Johnson & Johnson is 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.
About Johnson & Johnson
As the science of human health and well-being has grown, we've been able to grow with it. Even more important, we've helped shape and define what health and well-being
means in everyday lives. Our products, services and ideas now touch the lives of at least one billion people every day. We credit our strength and endurance to a consistent approach to managing our business, and to the character of our people.
We are looking to process the first round of applications within the next 2 working days.
We do not accept applications via email.
Diversity, Equity & Inclusion
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 are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each 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”.