INNOVATION IS OUR PASSION
Securecell is a 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. This expertise and experience have provided the foundation for the technology transfer into the MedTech space and the development of Seraccess, a truly disruptive diabetes therapy. Continuing on our sustainable innovation path and growth journey, we are looking for talented individuals to join our team as a
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 reporting to our Lead of Quality Assurance and Regulatory Affairs. This position involves coordinating cross-functional activities of the Validation and Qualification program for computer systems, laboratory, development, and manufacturing equipment. You will also be the key contact person supporting all Qualification and Validation activities for customers implementing our own software and computerized systems. You will lead software compliance during applications and systems development while closely collaborating with our interdisciplinary teams. Among your responsibilities, you will:
- Act as a key contact person for all validation activities, including supplier self-assessment and preliminary clarifications 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 systems development and create compliance strategies for software from requirements definition to implementation and testing.
- Build and maintain the processes for Qualification and Validation to ensure compliance, collaborating with project managers to integrate activities into implementation timelines.
- Moderate and document Quality Risk Assessments related to the executed validation activities.
- Determine validation deliverables and oversee the execution of validation plans and documents.
- Supervise, review, and document all validation activities (e.g., VPs, URS, FRS, RAs, IQs, OQs, PQs, VRs) based on internal and external needs.
- Evaluate proposed changes for validated processes and computer systems to recommend the necessary validation activities.
- Establish all Quality System-related documents, procedures, and templates in collaboration with relevant stakeholders.
- Create and implement training material and courses for the proper execution of validation documents, coaching teams for implementation.
- Implement compliance strategies for data analysis processes and integrated AI tools, including machine learning tools audits.
- Support projects in cybersecurity compliance and assessments.
- Collaborate 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 similar field, along with a minimum of ten years of relevant experience 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, including key validation approaches such as validation lifecycle, GAMP5, and V-Model.
- Experience in commissioning large-scale projects for bioprocess/pharmaceutical production facilities, facilitating compliance processes for both physical and digital environments (including IT infrastructure qualification and computerized systems integration).
- Practical experience managing and validating laboratory equipment and overseeing quality control processes.
- Experience working in clean rooms and a deep understanding of contamination control strategies in Biotech or pharmaceutical companies.
- Demonstrated ability in auditing biotech and pharmaceutical manufacturing processes (GxP), software development processes, and cloud infrastructure suppliers, while managing service level and quality agreements with cloud service suppliers (SaaS, PaaS, IaaS).
- Knowledge of GxP, ISO 13485, CSV, GAMP, and relevant regulations (21 CFR part 11, 21 CFR 210/211 and/or 820).
- Strong proficiency in MS Office suite and technical documentation tools; familiarity with Large Language Models will be an advantage.
- Effective stakeholder management skills with the ability to manage tight timelines and scopes.
- Strong collaboration and communication skills with subject matter experts from various functional areas.
- Highly organized and detail-oriented work style.
- Interpersonal, autonomous, and equipped with an analytical and critical mindset.
- Excellent spoken and written English (native speaker or equivalent level), with a good understanding of German preferred.
- Valid work permit for Switzerland; only direct applicants will be considered (no agencies).
OUR OFFER
Securecell offers a highly diverse international working environment, providing an opportunity to collaborate with highly 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 marketed products. We nurture true innovation and creative thinking to advance our research projects and continuously improve our offerings. At Securecell, you will find a challenging role, inspiring colleagues, and a meaningful purpose. We look forward to hearing from you!
Apply online using the form below.
JOB LOCATION
Securecell headquarters are located in Urdorf (Zurich), Switzerland.