INNOVATION IS OUR PASSION
Securecell is a trusted partner for biopharma, enabling the safe, efficient, and economical delivery of new therapies to patients. We specialize in groundbreaking measuring and control engineering technologies that significantly improve bioprocessing, medical treatment, and patient health. With over 25 years of experience, we have been providing innovative solutions in bioprocess control for biotech, pharma, and academia. Our expertise has paved the way for technology transfer into the MedTech space, leading to the development of Seraccess, a truly disruptive diabetes therapy. As we continue on our path of sustainable innovation and growth, we are seeking talented individuals for the position of:
VALIDATION MANAGER
Join our Biotech Department as a Validation Manager, where you will play a pivotal role in establishing and owning our validation strategy, procedures, and instructions with a strong focus on risk-based approaches to Validation and Good Manufacturing Practices. In this role, you will be part of an international team and report to our Lead of Quality Assurance and Regulatory Affairs. You will oversee cross-functional activities of the Validation and Qualification program while supporting all Qualification and Validation activities for customers implementing our software and computerized systems. Your responsibilities will include:
- Acting as the primary contact for all validation activities, including supplier self-assessment and preliminary clarifications with customers.
- Developing a compliant validation and test strategy based on risk assessment for internal computerized systems, ensuring cost-efficient implementation and setting industry standards.
- Participating in projects for systems development and creating compliance strategies for software from requirements definition to implementation and testing.
- Building and maintaining processes for Qualification and Validation to ensure compliance, collaborating with project managers to integrate qualification and validation activities into implementation timelines.
- Moderating and documenting Quality Risk Assessments related to validation activities.
- Determining validation deliverables and overseeing the execution of validation plans and related documents.
- Supervising, reviewing, and documenting all validation activities (e.g., VPs, URS, FRS, RAs, IQs, OQs, PQs, VRs) per internal and external needs.
- Evaluating proposed changes to validated processes and computer systems to define the necessary validation activities.
- Establishing Quality System-related documents, procedures, and templates in collaboration with relevant stakeholders.
- Creating and implementing training materials and courses for the proper execution of validation documents and coaching teams on implementation.
- Implementing compliance strategies for Data Analysis processes and integrated AI tools (including auditing machine learning tools).
- Supporting projects in cybersecurity compliance and assessment.
- Collaborating with the IT team to enhance IT infrastructure, disaster recovery processes, and ensure business continuity.
YOUR PROFILE
- At least a Bachelor’s degree in engineering, sciences, or a related field with a minimum of ten years of proven experience in Process Validation and Computer System Validation within Biotechnology or Medical Devices.
- Proven scientific and technical expertise in qualification and process validation in the Life Sciences/Pharmaceutical industry and familiarity with key validation approaches (validation lifecycle, GAMP5, V-Model).
- Experience in commissioning large-scale projects within bioprocess/pharmaceutical production facilities, including compliance processes for physical and digital environments.
- Practical experience in managing and validating laboratory equipment and overseeing quality control processes.
- Experience working in clean rooms and a deep understanding of contamination control strategies in the Biotech or pharmaceutical sector.
- Experience in auditing biotech and pharmaceutical manufacturing processes (GxP), software development processes, and/or cloud infrastructure suppliers.
- Knowledge of GxP, ISO 13485, CSV, GAMP, 21 CFR part 11, 21 CFR 210/211, and/or 820.
- Strong proficiency in MS Office and other tools for technical documentation; familiarity with tools based on Large Language Models is advantageous.
- Confident stakeholder management skills with the ability to manage tight timelines and scopes.
- Strong collaborative and communication skills with subject matter experts across various functional areas.
- A highly organized and detail-oriented work style with analytical and critical thinking abilities.
- Excellent spoken and written English (native speaker or equivalent level), ideally with a good understanding of German.
- A valid work permit for Switzerland; only direct applicants will be considered (no agencies).
OUR OFFER
At Securecell, we offer a highly diverse international working environment and the opportunity to collaborate with skilled individuals from various disciplines. Partnership and interdisciplinary collaboration are fundamental to our company, our research efforts, and the commercialization of our products. We foster true innovation and creative thinking to advance our research projects and continuously improve our offerings. Join us for a challenging role, inspiring colleagues, and a meaningful purpose.
Apply online using the form below. Please note, only applications matching the job profile will be considered.
JOB LOCATION
Securecell's headquarters are located in Urdorf (Zurich), Switzerland.