Johnson & Johnson
CSV Engineer
CSV Engineer
Location: Bern Onsite
Duration: 8 months
Imagine your next step, working for Johnson & Johnson - as a CSV Engineer in Bern.
At Janssen, we’re creating a future where disease is a thing of the past. We’re the Pharmaceutical Companies of Johnson & Johnson, working tirelessly to make that future a reality for patients everywhere by fighting sickness with science, improving access with ingenuity, and healing hopelessness with heart. We focus on areas of medicine where we can make the biggest difference: Cardiovascular & Metabolism, Immunology, Infectious Diseases & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension.
Tasks and Responsibilities: - Technical Services and all other departments on site which rely on CSV services
Aim of the position
In charge of Computer System Validation (CSV) activities for Technical Services department in order to ensure that:
Validation phases are performed according to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities
Validation Master plans are up to date and established for all ongoing projects
A minimum of 3 days per week of site presence is required.
Due to the nature of the position and the tasks to be performed, it may be required to be more than 3 days per week on site, based on demand. Therefore, living in a regular commutable distance from Bern is advisable.
Essential duties
Assess and lead the CSV package(s) on an assigned project.
Taking accountability for the work to be produced by yourself and other colleagues that are under the assigned packages lead by this position.
Hands on: Plan, coordinate and execute all phases for computer system validation of production and QC Lab systems including but not limited to, Validation plans, FMEA, RTM, DQ, IQ, OQ, Validation Reports.
Perform CSV periodic review of equipment and systems.
Prepare, review, and approve technical and GMP related documentation (URS, impact/risk assessment, Master plans, qualification/validation documentation)
Understand customer needs and define electronic records requirements for computerized system adhering to regulation and company standards
Coordinate and execute FAT/SAT, commissioning activities focused on CSV for new systems in collaboration with internal and external partners
Validation planning for base business including interaction with IT, Maintenance Automation and Quality Operations groups
Coordination and oversight of external subcontractors / software suppliers when required
Operational handling of Change Controls, CAPAs and Non-Conformances related to CSV
Contribute to ensure that changes introduced in the organization of systems, procedures, processes and formulas are managed so that all aspects of the equipment / computerized systems are assessed and resolved.
how to succeed
Experiences Required
Bachelor/master’s degree in technical or natural sciences
Ability to work in a fast-changing environment
A minimum of 3 years of working experience within pharma or a biotech company
Experience on validating computerized manufacturing equipment (CSV context)
Experience on validating software & hardware infrastructure (e-g: servers, network and software services).
A minimum of 4 years of working experience with CSV
Know-how of CSV requirements according to FDA 21CFR part 11/ EUGMP Annex 11 regulations and ISPE GAMP 5 guidelines
Excellent communication skills
Analytical thinking and problem-solving ability
Ability to work under minimal supervision; Assess priorities and work well under pressure in a fast-paced environment
Ability to effectively work as part of a multidisciplinary, international team
Business fluency in English Preferred
German language
Experience on validating complex computerized analytical equipment (QC Laboratory equipment)
Basic know-how of Validation requirements according to cGMP regulations
Basic know-how of quality assurance principles
What’s in it for you?
As the biggest health company in the world, we find it important to put the needs and well-being of our customers and employees first. Our recipe for success consists of crafting an inclusive work environment where everybody feels welcome and respected.
At Johnson & Johnson, we blend heart, science and ingenuity to profoundly change the trajectory of health for humanity.
https://www.janssen.com/about
benefits
This role offers a very competitive hourly rate.
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
Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.
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”.