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 ground-breaking 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. This expertise and experience provided the foundation for the technology transfer into the MedTech space and the development of Seraccess, a truly disruptive diabetes therapy. Continuing steadily on our sustainable innovation path and growth journey, we are looking for talented individuals to join our team.
POSITION AVAILABLE: VALIDATION MANAGER
We are seeking a Validation Manager for our Biotech Department. In this role, you will be responsible for establishing and overseeing the validation strategy, procedures, instructions, and related scientific content, with an emphasis on risk-based approaches to Validation and Good Manufacturing Practices. As a key member of an international team, you will report to our Lead of Quality Assurance and Regulatory Affairs and coordinate cross-functional activities of the Validation and Qualification program for computer systems as well as laboratory, development, and manufacturing equipment. Your primary responsibilities will include:
- Acting as a key contact person for all validation activities, including supplier self-assessment and preliminary clarification 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 the process for Qualification and Validation to ensure compliance, collaborating with project managers to incorporate activities into implementation timelines, and coordinating all validation-related projects.
- Moderating and documenting Quality Risk Assessments related to executed validation activities.
- Determining validation deliverables and overseeing the execution of validation plans and documents.
- Supervising, reviewing, and documenting all validation activities (e.g., VPs, URS, FRS, RAs, IQs, OQs, PQs, VRs) based on internal and external requirements.
- Evaluating proposed changes for both validated processes and computer systems to define the recommended level of validation activities required.
- Establishing Quality System-related documents, procedures, and templates in collaboration with relevant stakeholders.
- Creating and implementing training materials and courses for the execution of validation documents and coaching teams on implementation.
- Implementing compliance strategies for data analysis processes and integrated AI tools (including machine learning tools audit).
- Supporting projects in cybersecurity compliance and assessment.
- Collaborating with the IT team to improve 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 in Biotechnology or Medical Devices.
- Demonstrated scientific and technical expertise in qualification and process validation within the Life Science / Pharmaceutical industry, along with key validation approaches (validation lifecycle, GAMP5, V-Model).
- Experience in commissioning large-scale projects for bioprocess/pharmaceutical production facilities, including compliance processes for both physical and digital environments.
- Practical experience in managing and validating laboratory equipment and overseeing quality control processes.
- Experience working in clean rooms and a solid understanding of contamination control strategies in Biotech or pharmaceutical environments.
- Proficiency in auditing biotech and pharmaceutical manufacturing processes (GxP), software development processes, and/or cloud infrastructure suppliers, along with service level and quality agreements management with cloud service suppliers (SaaS, PaaS, IaaS).
- Knowledge of GxP, ISO 13485, CSV, GAMP, 21 CFR part 11, 21 CFR 210/211, and/or 820.
- Strong skills in MS Office suite and other tools used for technical documentation; knowledge of tools based on Large Language Models is an advantage.
- Confident stakeholder management skills, with the ability to manage tight timelines and project scopes.
- Adept at collaboration and communication with subject matter experts across different functional areas.
- Highly organized and structured work style, with a strong attention to detail.
- Interpersonal and autonomous with an analytical and critical mindset.
- Excellent spoken and written English (native speaker or equivalent); good understanding of German is a plus.
- Valid work permit for Switzerland; only direct applicants will be considered (no agencies).
OUR OFFER
Securecell provides 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, underpinning our research activities and the commercialization of our products. We foster true innovation and creative thinking to advance our projects and continuously improve our offerings. At Securecell, you will experience a challenging role, inspiring colleagues, and a meaningful purpose. We look forward to hearing from you soon!
Apply online using the form below.
JOB LOCATION
Securecell’s headquarters are located in Urdorf (Zurich), Switzerland. Only applications matching the job profile will be considered.