Johnson & Johnson
Equipment Engineer
Job Title: Equipment Engineer
Location: Bern
Hours: 40
Essential: Experience within equipment, validation
The role
In this role, you will be responsible for Qualification and Validation activities for new QC laboratory department.
The Experienced Validation Engineer is primarily responsible that Qualification and Validation studies are carried out to conform to global and local company policies and procedures as well as legal requirements and requirements set by regulatory authorities.
Under general supervision performs technical work, provides validation and project management services and/or develops concepts, assessments, and details under moderate supervision. Carries out all the validation tasks and as needed the Experienced Validation Engineer will be able to design and execute independently all the validation activities and interpret the results to properly make the final statement of the validation outcome.
Key Responsibilities:
Define strategy, plan, coordinate and execute the core business phases of Qualification and Validation activities based on specific assigned role and responsibilities.
Ensure the Qualification and Validation activities are properly planned and executed as per Lifecycle Process Validation process.
Ensures the validation activities are reported back in the applicable site Supporting Validation Plans and Validation Master Plans
Authoring, review and approve validation plans, protocols, reports.
Perform risk/criticality assessments, technical and GMP related documentation.
Bridging with multi-functional teams handling and ensuring facilities, equipment, and process readiness for GMP production.
Works with greater autonomy for longer term activities independently interpreting data, identifying project needs, and proposing solutions.
Collects and collates results and inferences and reports to project team and senior colleagues.
Collaborates effectively with fellow project members following priorities, checkpoints, and timelines in support of objectives.
Additional Information
Define strategy, plan, coordinate and execute all phases for Qualification and Validation activities:
Dry heat oven: chamber and load thermal mapping
Washing machine: cleaning validation
Isolator: VHP, integrity studies and EMPQ
Supporting engineering, quality, QC and production in a campus-wide validation team.
May coordinate and oversight of external validation partners.
Qualifications:
MSc degree (or BSc with increased level of experience: 5-7 years) in technical or life sciences
A minimum of 3-5 years of working experience within pharma company in validation or equivalent position
Experience working in project teams
Profound know-how of Validation requirements according to cGMP regulations
Basic Know-how of QC processes
Analytical thinking and problem-solving ability
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.com
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”.