Production Engineer

Production Engineer (Equipment, GMP, CaPEX)

Location: Bern, Switzerland

Hours: 40h, onsite

Languages: English (fluent), German (Conversational)

Imagine your next role as a Production / Process Engineer working within the systems life cycle team.

You will be part of a team in the execution of the System Life Cycle Process for the simple GMP systems in Bern, acting as System Owner, Subject Matter Expert and Single Point Of Contact for such systems.

Key responsibilities:

• Domain expert for new and existing GMP simple systems used in all manufacturing processes in the site of Bern (including but not limited to: refrigerators, freezers, incubators, sealers, bench equipment...)

• Preparation, review and approve technical and GMP related documentation (such as URS, impact/risk assessment, calibration list...) in collaboration with internal partners and system Suppliers

• Ensure that changes to systems, procedures and processes are appropriately handled such that resulting impact on equipment / systems GMP state are assessed and resolved

• Creation, processing, tracking and closing of ETS records (QI, CAPA, CC) related to production systems and equipment, ETS record ownership as needed

• Supports Compliance team with SOP, WIs, Job aids harmonization initiatives across site

For the systems owned:

• Input, review and sign off on design documentation

• Organization of meetings and status reporting, leading the System Owner Agenda and coordinate with different teams and coworkers to accomplish tasks

• C&Q, CSV and Validation: input on assessments and plans, support on protocol execution.

• Organizes training to the users (both coordinating external suppliers or delivering the training in first person)

• Ownership of the Log Book, with regular inspections to verify it’s correctly filled in and updated

• Responsibility for updating / maintaining master data in SAP

• Coordination of maintenance intervention including closure of Work-Orders

• Support for inspection readiness, requests from internal and external audits / inspections, and follow-up performing assigned actions, as needed

how to succeed:

• MSc degree or equivalent experience (or BSc with increased level of experience: at least 2 years Master degree or 5 years bachelor degree relevant experience ) in technical or life sciences

• Ability to work with weekly under limited supervision and assume personal ownership and accountability for business results and solutions

• Biotechnology or Pharmaceutical industry experience

• Know-how of quality assurance principles

• Business proficiency in English

• German language is an advantage

Benefits

This role offers a competitive hourly rate & a supportive working environment. 

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.

https://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. Please apply via the link.

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”.