Compliance Engineers - Parenterals, Packaging, Optical Inspection, Utilities, or API/Solids
Location: Schaffhausen, Switzerland (hybrid working 3 days onsite/2 days home office)
Duration of the contract: Until Dec 31st, 2026 (likely to be extended)
Hours per week: 40 hours
Essential: Fluent German and English is required - 5 years plus within Compliance - Proven track record in a GMP environment, pharmaceutical / biotech / medical devices industry (Parenterals, Packaging, Optical Inspection, Utilities, or API/Solids).
Imagine your next project acting as the vital bridge between cutting-edge engineering and life-saving quality standards.
At our Janssen Operations site in Schaffhausen, one of the most modern pharmaceutical production sites in Europe, we combine high-tech manufacturing with a "Quality First" mindset. We are seeking a Compliance Engineer to join our Global Engineering Team (GET). In this pivotal role, you will act as the operational backbone for our engineering teams, ensuring that technical projects meet the highest standards of Quality and Compliance.
roles and responsibilities
You will be the "bridge" between technical record owners and Quality Assurance, specifically focusing on managing records within the COMET system.
This will involve:
* Quality Systems Management: Operationally manage and maintain COMET records (Non-Conformances and Change Controls), ensuring all entries are verified and completed in collaboration with technical owners.
* Risk Assessment Facilitation: Prepare, moderate, and coach Risk Assessment meetings (e.g., FMEA). You will ensure that internal standards and GMP requirements are strictly followed.
* Engineering Support: Act as a consultant to the engineering teams, gathering technical inputs and structuring documentation to ensure audit-readiness.
* Tracking & Compliance: Proactively monitor due dates and follow up on action items to ensure timely closure of records.
* QA Interface: Maintain a strong connection with Quality Assurance (QA/QAE) teams and elevate risks or deviations promptly.
* Reporting: Provide regular status updates to GET management regarding open actions, risk assessments, and deadline statuses.
how to succeed
You are a detail-oriented professional with a "Getting Things Done" attitude and a deep understanding of the pharmaceutical regulatory landscape.
You will also bring:
* Degree in Engineering, Life Sciences, or a comparable technical qualification.
* Fluent in German & English is essential
* Proven track record (5+ years) in a GMP environment (Pharmaceutical/Biotech/MedTech).
* Experience in Parenterals, Packaging, Optical Inspection, Utilities, or API/Solids.
* Fluent German and Professional English skills.
* Familiarity with electronic Quality Management Systems (e.g., COMET, TrackWise).
* Experience with Risk Assessment methodologies like FMEA or HAZOP.
* Excellent moderation and coaching skills to manage multiple stakeholders.
* Previous experience within the Johnson & Johnson family is a significant advantage.
benefits
This role offers a very competitive hourly rate. This contract will run for until Dec 31st, 2026 (with likely extension).
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 Innovative Medicine
Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow. Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina. We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.
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”.
#J-18808-Ljbffr