INNOVATION IS OUR PASSION
Securecell is the trusted partner for biopharma, enabling them to bring new therapies to patients in a safe, efficient, and economical way. We innovate groundbreaking measuring and control engineering technologies to radically improve bioprocessing, medical treatment, and patient health. For more than 25 years, we have been delivering innovative solutions in bioprocess control for biotech, pharma, and academia. Our expertise has laid the foundation for technology transfer into the MedTech space and the development of Seraccess, a truly disruptive diabetes therapy. As we continue our journey of sustainable innovation and growth, we are seeking talented individuals for the position of:
VALIDATION MANAGER
for our Biotech Department
In this role, you will be responsible for establishing and owning the validation strategy, procedures, instructions, and related scientific content, with an emphasis on risk-based approaches to Validation and Good Manufacturing Practices. You will be part of an international team and report to the Lead of Quality Assurance and Regulatory Affairs. You will coordinate cross-functional activities of the Validation and Qualification program for computer systems, as well as for laboratory, development, and manufacturing equipment. Additionally, you will be the key contact for supporting all Qualification and Validation activities for customers implementing our software and computerized systems while leading software compliance throughout the applications and systems development lifecycle.
Your Responsibilities:
- Act as a key contact person for all validation activities, including supplier self-assessment and preliminary clarification with customers.
- Develop a compliant validation and test strategy based on risk assessment for internal computerized systems, ensuring cost-efficient implementation and setting industry standards.
- Participate in projects for system/application development and create compliance strategies for software from requirements definition to implementation and testing.
- Build and maintain the process for Qualification and Validation to ensure compliance; collaborate with project managers to incorporate qualification and validation activities into implementation timelines.
- Moderate and document Quality Risk Assessments related to executed validation activities.
- Determine validation deliverables and oversee the execution of validation plans and validation documents.
- Supervise, review, and document all validation activities (e.g., VPs, URS, FRS, RAs, IQs, OQs, PQs, VRs) based on internal and external requirements.
- Evaluate proposed changes for both validated processes and computer systems to define the recommended level of validation activities required.
- Establish all Quality System-related documents, procedures, and templates, collaborating with relevant stakeholders.
- Create and implement training materials and courses for the proper execution of validation documents and coach teams on effective implementation.
- Implement compliance strategies for data analysis processes and integrated AI tools, including machine learning tools audit.
- Support projects in cybersecurity compliance and assessment.
- Collaborate with the IT team to improve IT infrastructure, disaster recovery processes, and ensure business continuity.
Your Profile:
- At least a Bachelor’s degree in engineering, sciences, or a similar field with relevant proven experience of at least ten years in Process Validation and Computer System Validation in Biotechnology or Medical Devices.
- Proven scientific and technical expertise in qualification and process validation in the Life Science/Pharmaceutical industry and associated key validation approaches (validation lifecycle, GAMP5, V-Model).
- Demonstrated experience in commissioning large-scale projects for bioprocess/pharmaceutical production facilities, facilitating compliance processes in both physical and digital environments (including IT infrastructure qualification, computerized systems integration, and digitalization).
- Practical experience managing and validating laboratory equipment along with managing quality control processes.
- Experience working in clean rooms and a deep understanding of contamination control strategies in Biotech or pharmaceutical companies.
- Proven experience auditing biotech and pharmaceutical manufacturing processes (GxP), software development processes, and/or cloud infrastructure suppliers, including managing service level and quality agreements with cloud service suppliers (SaaS, PaaS, IaaS).
- Familiarity with GxP, ISO 13485, CSV, GAMP, 21 CFR part 11, 21 CFR 210/211, and/or 820.
- Proficient in the MS Office suite and other tools used in state-of-the-art technical documentation; knowledge of tools based on Large Language Models is an advantage.
- Excellent stakeholder management skills, with the ability to manage tight timelines and project scopes.
- Strong collaborative and communication skills with subject matter experts from different functional areas.
- Highly organized and structured work style with a keen attention to detail.
- Proactive and analytical with a critical mind.
- Excellent spoken and written English (native speaker or equivalent level), with a good understanding of German being an advantage.
- Valid work permit for Switzerland; only direct applicants will be considered (no agencies).
Our Offer:
Securecell offers a highly diverse international working environment and the opportunity to collaborate with skilled individuals from various disciplines. Partnership and interdisciplinary collaboration are at the core of our company, our research activities, and the commercialization of our marketed products. We foster true innovation and creative thinking to advance our research projects and continuously improve our marketed products. At Securecell, you will encounter a challenging role, inspiring colleagues, and a true purpose. We look forward to hearing from you!
Apply online using the form below. Only applications matching the job profile will be considered.
Job Location:
Securecell’s headquarters are located in Urdorf (Zurich), Switzerland.