Janssen Supply Group, a member of Johnson & Johnson's Family of Companies, is recruiting for a Staff Engineer, Combination Product and Device Quality that can be based in Fremont, CA, Titusville, NJ, Malvern, PA, Springhouse, PA, Raritan, NJ, Los Angeles, CA, Beerse Belgium, Schaffhausen Switzerland, or Latina Italy with possibly flexibility on other locations.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us.
We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it.
Learn more at and follow us JanssenGlobal. Janssen Supply Group, LLC, is part of the Janssen Pharmaceutical Companies.
The Staff Engineer, Combination Product & Device Quality acts as the Quality Engineering Subject-Matter-Expert on Drug-Device Combination Product Programs.
The candidate shall use quality principles and tools to develop and optimize product designs, manufacturing processes, quality systems etc.
Works on problems of diverse scope where analysis of data is required.
Uses education, knowledge and experience to bring the Drug-Device Combination products through development and launch.
Represents Quality Engineering on the New Product Development teams
Ensures standard processes and norms are used across sites and facilitates communication throughout Quality organization
Responsible for communication of issues to appropriate Quality Management.
Reviews and approves cGMP / QSR documents for site, JSC procedures, specifications, non-conformance / events, protocols, reports, technical memos and change controls.
Assists with regulatory visits, corporate audits and vendor audits.
Provides follow up on regulatory commitments.
Participates in Design & Development, Design Transfer and post transfer Lifecycle Management.
Leads preparation of Quality portion of Design Review and Combination Product Stage Gate Exit
Leads, conducts and own quality risk assessment activities
Collaborates with business partners to meet goals and objectives, find opportunities and drive projects forward.
Builds networks to maintain trust.
Reviews regulatory submissions and supporting documentation.
Additional responsibilities / duties :
Develops and applies advanced knowledge. May work in other areas as the need arises.
Assures personal training and skill levels remain current by promptly completing assigned training and remaining current in professional and industry knowledge / trends.
May participate / facilitate in any required meetings related to combination products as a department representative.
Maintains relevant and necessary GMP, QSRs, and knowledge of applicable laws.
Assists in the development and training of staff members.
May attend project team meetings as needed and communicate outcomes to supervisor.
Follows all state and federal regulations and guidelines including FDA, EPA, and OSHA, as well as all company and site policies and procedures.
Participates on technical or other internal teams.
Carries out duties in compliance with all local, state and federal regulations and guidelines including FDA, EPA, OSHA, and global health authorities as applicable.
Follows all company and site policies and procedures.
Successfully completes regulatory and job training requirements.
Autonomy and complexity :
Can lead technical and quality discussions to resolve Quality issues
Runs multiple products and teams simultaneously
Makes decisions independently.
Proactively identifies issues and takes steps to resolve within team.
Analyzes issues and figures out how to apply policies and processes to meet team goals.
Presents department objectives to senior management as needed.
Bachelor’s Degree in Engineering, Chemistry, Biology, Statistics or other scientific field, with is required.
A minimum of 6 years related experience is required
Medical device, pharma experience, biopharmaceutical experience is required
Experience with Device Quality Systems / Design Control / QSR, cGMP, and ICH is required
Excellent technical writing skills; experienced in SOPs, protocols, reports is highly preferred.
Knowledge of device design, process engineering, and bioprocessing manufacturing and test processes is required.
Project management training or experience preferred
Conflict Management skills required.
Working Knowledge of Statistical Methods / Processes
SPECIAL TRAINING or CERTIFICATION :
ASQ certification as a Quality or Reliability Engineer and Six Sigma Green Belt certification & Black belt training preferred
Travel requirements :
Up to 25% local travel
10% International travel
Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability