The Engineer System Lifecycle collaborates closely with other departments to ensure the system functionality in routine and extra-routine phases, involving the Suppliers to implement improvements or problem fixing, and leading or supporting quality investigations and remediations. He/She is the Subject Matter Expert, Single Point Of Contact and System Owner for DLS (Data Logging System), Tulip (e-MBR) and responsible for automation compliance topics and related process (focus but not limited to).
Main Responsibilities:
Domain expert for new and existing DLS (Data Logging System), Tulip (e-MBR) and highly automated systems used in manufacturing processes at the Bern site
Preparation, review and approve technical and GMP related documentation (such as SIA, URS, FMEA, impact/risk assessment) in collaboration with internal partners and system suppliers
Contribution to ensure that changes to systems, procedures and processes are appropriately handled such that resulting impact on equipment / systems GMP state are assessed and resolved
Explains work with independent analysis and conclusions related to assigned tasks through written and oral communication.
Organization of meetings and status reporting, leading the System Owner Agenda and coordinate with different teams and coworkers to accomplish tasks
Support in the creation, processing, tracking and closing of ETS records (NC, CAPA, CC) related to production systems and equipment, ETS record ownership as needed
C&Q, CSV and Validation: input on assessments and plans, support on protocol execution.
Supports Compliance team with SOP, WIs, Job aids harmonization initiatives across site
Leads in troubleshooting and resolving equipment, systems, and process problems to prevent the occurrence of product and process nonconformities
Input, review and sign off on design documentation with support of Sr team members as needed
Organizes training to the users (both coordinating external suppliers or delivering the training in first person)
With the Manager support, review of Service Level Agreement with the Supplier
Ownership of the system Log Book, with regular inspections to verify it's correctly filled in and updated
With the Manager support, coordination of maintenance intervention including closure of WorkOrders, optimizing maintenance budgets, maintenance plans, long term equipment replacement plans, and spare part sourcing strategies
Responsibility for updating / maintaining master data in SAP
Support compilation of costs for CAPEX and OPEX application (supplier quotations, purchase order and internal workload estimation)
Support for inspection readiness, requests from internal and external audits / inspections, and follow-up performing assigned actions, as needed
?
Associate Engineer System Lifecycle (f/m/x)
The Engineer System Lifecycle collaborates closely with other departments to ensure the system functionality in routine and extra-routine phases, involving the Suppliers to implement improvements or problem fixing, and leading or supporting quality investigations and remediations. He/She is the Subject Matter Expert, Single Point Of Contact and System Owner for DLS (Data Logging System), Tulip (e-MBR) and responsible for automation compliance topics and related process (focus but not limited to).
Main Responsibilities:
Domain expert for new and existing DLS (Data Logging System), Tulip (e-MBR) and highly automated systems used in manufacturing processes at the Bern site
Preparation, review and approve technical and GMP related documentation (such as SIA, URS, FMEA, impact/risk assessment) in collaboration with internal partners and system suppliers
Contribution to ensure that changes to systems, procedures and processes are appropriately handled such that resulting impact on equipment / systems GMP state are assessed and resolved
Explains work with independent analysis and conclusions related to assigned tasks through written and oral communication.
Organization of meetings and status reporting, leading the System Owner Agenda and coordinate with different teams and coworkers to accomplish tasks
Support in the creation, processing, tracking and closing of ETS records (NC, CAPA, CC) related to production systems and equipment, ETS record ownership as needed
C&Q, CSV and Validation: input on assessments and plans, support on protocol execution.
Supports Compliance team with SOP, WIs, Job aids harmonization initiatives across site
Leads in troubleshooting and resolving equipment, systems, and process problems to prevent the occurrence of product and process nonconformities
Input, review and sign off on design documentation with support of Sr team members as needed
Organizes training to the users (both coordinating external suppliers or delivering the training in first person)
With the Manager support, review of Service Level Agreement with the Supplier
Ownership of the system Log Book, with regular inspections to verify it's correctly filled in and updated
With the Manager support, coordination of maintenance intervention including closure of WorkOrders, optimizing maintenance budgets, maintenance plans, long term equipment replacement plans, and spare part sourcing strategies
Responsibility for updating / maintaining master data in SAP
Support compilation of costs for CAPEX and OPEX application (supplier quotations, purchase order and internal workload estimation)
Support for inspection readiness, requests from internal and external audits / inspections, and follow-up performing assigned actions, as needed
?
qualifications
Must Haves:
MSc degree 0-2 years relevant experience in life sciences
BSs degree 2-5 years relevant experience in life sciences
At least 2 years of experience in GMP compliant biotechnological manufacturing or development
Fluency in English
Fluency in German is a plus
Knowledge of GMP-requirements and their technical implementation in cleanrooms
This job based in Bern, Switzerland will initially be limited to approx. 12 months. If you are interested in working with a global leading pharmaceutical company in a dynamic, progressive, and collaborative environment, then send us your application today. Or give us a call if you have any questions!
See what comes ahead in the application process. Find out how we help you land that job.
1 of 8
apply with randstad.
Applying with us is easy. We will review your application and see if you are a good fit for the job and the company.
2 of 8
we'll contact you.
Our consultant will call you at a suitable time to discuss your application and further career aspirations.
3 of 8
getting you registered.
If you’ve never worked with us before, we’ll need some basic additional pieces of information to confirm your eligibility to work in Switzerland.
4 of 8
compliance, reference and background check.
Next, we just need to verify a few things - we’ll make the relevant compliance checks and and in ensuring you’re perfect for the role, we’ll make contact with any relevant references you’ve provided and will keep you posted.
5 of 8
the perfect job for you.
Our expert team will either arrange an interview for the role you’ve applied for, or if they believe there’s a better opportunity, they’ll suggest alternative options too.
6 of 8
the interview.
We’ll ensure that you’re fully prepared ahead of your interview and know exactly what to expect - good luck!
7 of 8
start your new job.
Congratulations, you’re ready to begin your new job. The team will ensure that you’re fully prepared for your first day.
8 of 8
ongoing support.
After starting your new mission, we will contact you to check how you are doing and make sure you have our support in your new role.
Caring for the world … one person at a time inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Innovative Medicine work with partners in health care to touch t
Caring for the world … one person at a time inspires and unites the people of Johnson & Johnson. This culture of caring is the focus of our corporate philosophy, that is anchored in the internationally applicable Credo. We embrace research and science - bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Innovative Medicine work with partners in health care to touch t
Für die Welt sorgen … beim Einzelnen beginnen. Dieser Leitsatz inspiriert und eint die Menschen bei Johnson & Johnson. Die Kultur der Fürsorge steht im Mittelpunkt unserer Unternehmensphilosophie, welche im Credo verankert ist. Janssen Vaccines, ein Mitglied der Janssen Pharmaunternehmen von Johnson & Johnson, ist ein global agierendes, biopharmazeutisches Unternehmen, das sich erfolgreich mit der Entwicklung und Herstellung von innovativen Produkten besch
Für die Welt sorgen … beim Einzelnen beginnen. Dieser Leitsatz inspiriert und eint die Menschen bei Johnson & Johnson. Die Kultur der Fürsorge steht im Mittelpunkt unserer Unternehmensphilosophie, welche im Credo verankert ist. Janssen Vaccines, ein Mitglied der Janssen Pharmaunternehmen von Johnson & Johnson, ist ein global agierendes, biopharmazeutisches Unternehmen, das sich erfolgreich mit der Entwicklung und Herstellung von innovativen Produkten besch
let similar jobs come to you
We will keep you updated when we have similar job postings.
Thank you for subscribing to your personalised job alerts.
