Company Overview
Our Schachen site serves as a magnetic force that attracts, recognizes, and integrates individuals from diverse backgrounds and perspectives. Employees feel not only that they belong at Schachen, but also that the site is shaped by their contributions.
Schachen Biotech is a premier, state-of-the-art facility that integrates advanced technologies into the early-stage clinical pipeline, refining them for future commercial launch. This site supports biologics drug substance manufacturing for early-phase clinical supply and serves as a hub for technology innovation and strategic advancement.
Position Overview
The Compliance Excellence Specialist (P2) supports operational compliance and quality system activities for GMP biologics manufacturing at our Schachen site. This role contributes to right-first-time execution, operational continuity, and inspection readiness by supporting investigations, documentation, change controls, risk records, and continuous improvement activities within assigned areas.
Working under direction and guidance, the specialist applies developing GMP and quality system knowledge to address straightforward compliance topics, support timely closure of quality records, and contribute to cross-functional alignment with Manufacturing, Quality, Engineering, and MSAT. The position emphasizes reliable execution, learns through hands-on assignments, and builds the experience needed to independently manage broader compliance topics over time.
Responsibilities
- Compliance Support & Issue Resolution:
- Support the resolution of GMP deviation records, investigations, impact assessments, and CAPAs within assigned scope.
- Apply standard procedures and GMP expectations to assess issues and propose recommended actions with guidance.
- Assist in root cause analysis and CAPA definition by preparing inputs, gathering data, and documenting outcomes.
- Escalate risks, delays, or unclear situations in a timely and structured manner.
- Change & Risk Management:
- Support GMP product-related change controls and risk records under guidance.
- Collect and prepare information needed for risk assessments, change evaluations, and implementation planning.
- Ensure assigned documentation tasks are completed accurately and on time.
- Contribute to compliant and efficient execution of changes within area of responsibility.
- Operational Support:
- Provide compliance support for production-related questions, documentation topics, and issue follow-up.
- Assist Manufacturing teams in resolving standard and non-standard requests as needed.
- Collaborate with colleagues inside and outside the department to gather input and align next steps.
- Help ensure operational decisions remain aligned with GMP expectations.
- Performance Management & Continuous Improvement:
- Support monitoring and tracking of quality, compliance, and operational performance indicators.
- Contribute to data collection, trend review, and preparation of performance updates.
- Identify improvement opportunities within assigned tasks or processes and propose practical solutions.
- Participate in operational excellence activities such as Gemba, 5S, and process improvement routines.
- Inspection Readiness & Quality Systems:
- Support inspection readiness by helping ensure GMP documentation, deviations, investigations, and changes are complete, accurate, and inspection-ready.
- Participate in preparation activities for internal audits, external audits, and regulatory inspections.
- Maintain assigned records and documentation in accordance with procedural and compliance requirements.
- Support subject matter experts during audits or inspections when required.
- Project Support & Collaboration:
- Contribute to small projects, subteams, or workstreams with guidance.
- Deliver assigned project tasks according to agreed timelines and communicated expectations.
- Build effective working relationships with Manufacturing, Quality, Engineering, and MSAT.
- Actively learn from experienced colleagues and contribute to team knowledge sharing.
Your Profile
- Bachelor’s or Master’s degree in a scientific, engineering, or technical discipline.
- Initial experience in GMP-regulated manufacturing, quality systems, technical operations, or a related area.
- Good understanding of GMP expectations, documentation standards, and quality processes, with a willingness to further develop expertise.
- Ability to analyze issues using standard procedures and propose solutions with guidance.
- Strong collaboration skills and ability to work with colleagues across Manufacturing, Quality, Engineering, and MSAT.
- Strong communication skills in both German and English.
Company Commitment
Our company is a leading biopharmaceutical organization employing over 1,000 people in Switzerland across three sites. With headquarters in Lucerne, we operate a global innovation and development hub in Zurich and manufacture medicines for global clinical trials at our Schachen location, which includes a state-of-the-art forensic laboratory.
We conduct around 40 clinical trials annually in Switzerland, focusing on therapeutic areas such as oncology, infectious diseases, and cardiovascular health. Our diverse portfolio includes vaccines aimed at preventing diseases in children, adolescents, and adults, solidifying our status as a leader in veterinary medicine. Furthermore, we are dedicated to our local community through initiatives like the "Trendtage Gesundheit Luzern" and the "Alliance Health Competence."
We are proud to be certified as a “Top Employer Switzerland” and “Top Employer Europe,” reflecting our commitment to our employees and the surrounding community.
Additional Information
- Relocation: None
- Visa Sponsorship: None
- Travel Requirements: 10%
- Flexible Working Arrangements: Onsite
- Shift: No
- Valid Driver License: No
- Hazardous Materials: No
Application Process
Apply online using the form below. Only applications matching the job profile will be considered.