Process Validation Engineer

Process Validation Engineer  

Location: Bern

Duration: 12 month

Hours: 40 (3 days onsite/2 days home office)

Essential:  validation experience within pharma / medtec / equipment 

The Role 

In this role, you will be responsible for Process Validation activities for (new) biopharmaceutical processes in the Late Stage Development department. 

The Process Validation Engineer is primarily responsible that 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 Validation Engineer will be able to design and execute independently all the process validation activities and interpret the results to properly make the final statement of the validation outcome.

The Company

Employees of the Johnson & Johnson Family of Innovative Medicine work with partners in health care to touch the lives of over a billion people every day, throughout the world. We have more than 260 operating companies in more than 60 countries employing approximately 134,000 people. Our worldwide headquarters is in New Brunswick, New Jersey, USA.

Key Responsibilities

• Define strategy, plan, coordinate and execute the core business phases of Lifecycle Process validation activities based on specific assigned role and responsibilities.

• Ensure the 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.

How To Succeed

• Define strategy, plan, coordinate and execute all phases for supporting validation activities such as cleaning validation of product contact equipment, buffer hold time validation or mixing validation

• Define strategy, plan and coordinate of aseptic process simulation (APS)

• Define strategy, plan, execute and coordinate sterility assurance relevant supporting validation activities such as (but not limited to) smoke studies in operations, CCIT, sterile hold time, vessel integrity and filter validation.

• Support execution of Lifecycle Process validation activities such as process performance qualification (PPQ) and continued process validation (CPV)

• Define strategy, plan, execute and coordinate cleanrooms performance qualification.

• Define strategy, plan, execute and coordinate of process equipment performance qualification.

• Supporting engineering, quality, quality control and production in a campus-wide validation team.

• Coordination and oversight of external validation partners.

Experience & Qualifications:

• MSc degree (or BSc with increased level of experience: 5-7 years) in technical or life sciences

• A minimum of 3 years of working experience within pharma company in validation or equivalent position

• Experience working in project teams

• Experience in project management is a plus

  • Know-how of Validation requirements according to cGMP regulations

  • Basic Know-how of biotechnology processes

  • Analytical thinking and problem-solving ability

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 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. 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-beingmeans 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”.