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 have laid the foundation for technology transfer into the MedTech space and the development of Seraccess, a truly disruptive diabetes therapy. As we continue on our path of sustainable innovation and growth, we are looking for talented individuals to join our team.
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 our Lead of Quality Assurance and Regulatory Affairs. Your position will involve coordinating cross-functional activities of the Validation and Qualification program for computer systems, as well as laboratory, development, and manufacturing equipment. You will also serve as the key contact person to support all Qualification and Validation activities for customers implementing our software and computerized systems. You will lead software compliance during applications and systems development while closely collaborating with our interdisciplinary teams. Your responsibilities will include:
- Acting as a key contact person 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 and application development, 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 include qualification and validation activities in implementation timelines, and acting as a coordinator in all validation 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 needs.
- Evaluating proposed changes for validated processes and computer systems to define the recommended level of validation activities required.
- Establishing all Quality System-related documents, procedures, and templates with relevant stakeholders.
- Creating and implementing training materials and courses for the proper execution of validation documents and coaching teams for successful 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 enhance IT infrastructure, improve 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 experience in Process Validation and Computer System Validation in Biotechnology or Medical Devices.
- Proven scientific and technical expertise in qualification and process validation within the Life Sciences / Pharmaceutical industry, as well as familiarity with key validation approaches (validation lifecycle, GAMP5, V-Model).
- Extensive experience in commissioning large scale projects for bioprocess/pharmaceutical production facilities, including facilitating compliance in both physical and digital environments (IT infrastructure qualification, computerized systems integration, and digitalization).
- Practical experience in managing and validating laboratory equipment and overseeing quality control processes.
- Experience working in clean rooms with a strong understanding of contamination control strategies in biotech or pharmaceutical companies.
- Experience in auditing biotech and pharmaceutical manufacturing processes (GxP), software development processes, and cloud infrastructure suppliers, along with managing service level and quality agreements with cloud service providers (SaaS, PaaS, IaaS).
- Knowledge of GxP, ISO 13485, CSV, GAMP, 21 CFR part 11, and 21 CFR 210/211.
- Strong proficiency in the MS Office suite and other tools used for state-of-the-art technical documentation; familiarity with tools leveraging Large Language Models is an advantage.
- Excellent stakeholder management skills, with the ability to manage tight timelines and scopes effectively.
- Strong collaborative and communication skills with subject matter experts from various functional areas.
- A very organized and structured work style with meticulous attention to detail.
- Interpersonal, autonomous, and equipped with an analytical and critical mindset.
- Fluency in spoken and written English (native speaker or equivalent level), ideally complemented by a good understanding of German.
- Possession of a valid work permit for Switzerland; only direct applicants will be considered (no agencies).
OUR OFFER
Securecell offers a highly diverse international working environment, providing the opportunity to collaborate with skilled individuals from various disciplines. Partnership and interdisciplinary collaboration lie at the heart of our company, driving our research activities and the commercialization of our products. We foster true innovation and creative thinking to advance our research projects and continually improve our offerings. At Securecell, you will encounter a challenging job, inspiring colleagues, and a sense of true purpose. We look forward to hearing from you!
Apply online using the form below.
JOB LOCATION
Securecell's headquarters are located in Urdorf (Zurich), Switzerland.