Commissioning & Qualification Engineer

C&Q Engineer 

Location: Bern

Duration: until Dec 2023

Essential: English 

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

Benefits

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.

www.jnj.ch

Application Process

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”.