Computer System Validation Consultant
1 day ago
Madrid
Rephine Barcelona: Computer System Validation Senior Consultant Join Rephine Barcelona: Leading Life Sciences Quality Worldwide. At Rephine, we set the standard for quality assurance and GxP compliance in the Life Sciences industry. With offices in Barcelona, the UK, and China, India, we support the Pharmaceutical, Biotech, and Medical Device supply chains globally. Who We're Looking For: Are you passionate about consulting in the Pharma and Life Sciences sector? Do you thrive in dynamic environments, eager to take on multiple projects and drive real impact? If you're excited by the challenge of enhancing quality and compliance in a global company, we want you as our next Computer System Validation Senior Consultant in Barcelona. Your Role: As a CSV L2 Consultant , you will take an active role in delivering high-impact validation projects, focusing on ERP systems and other critical computerized systems in regulated environments. You will be part of innovative projects, ensuring compliance, efficiency, and quality across the lifecycle. Key Responsibilities Lead CSV Projects: Take ownership of ERP and other computerized system validations (IQ, OQ, PQ), preparing and reviewing critical documentation (VMP, URS, SOPs). Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines. ERP & System Expertise: Work hands‑on with ERPs, eDMS, eQMS, LIMS, laboratory systems, SCADA, EBRs, pharmacovigilance, and maintenance systems. Assess system compliance and performance to optimize regulatory readiness and operational efficiency. Audits & Compliance Assessments: Perform supplier audits and compliance checks, focusing on Annex 11, 21 CFR Part 11, and global regulations. Identify risks, provide actionable recommendations, and ensure corrective measures are implemented. International Project Engagement: Contribute to projects across Spain, Europe, and China, adapting to diverse regulatory environments. Represent Rephine on‑site with clients, ensuring seamless collaboration and delivering high‑quality results. Project Delivery & Client Success: Manage timelines and ensure all deliverables, including documentation and test execution, are completed on schedule. Maintain clear communication with stakeholders and provide progress updates regularly. Why This Role Could Excite You Take a leading role in ERP validation projects while expanding your CSV expertise. Work with international teams and cutting‑paced consulting environment. Be recognized as an L2 expert contributing to both client success and Rephine’s high standards. What You Bring A Bachelor’s degree in Chemistry or Engineering. Solid experience in the pharmaceutical industry, GxP compliance, and computerized systems validation. Strong multitasking skills and experience in managing multiple consulting projects to meet client needs. Fluency in Spanish and English, with excellent communication skills. Since client sites are often not easily accessible by public transportation, a valid driver’s license and willingness to travel by car are required. Is This Role for You? Ask yourself: Are you excited about working on‑site with clients to tackle their most critical challenges? Can you maintain a sense of ownership and connection to the Rephine team, even when managing demanding client‑facing responsibilities? Do you have the adaptability to move between technical tasks, regulatory compliance, and client interaction with ease? Are you ready to learn and grow in a role that exposes you to a wide range of systems and industries? If your answer is "yes" to these questions, then this opportunity at Rephine is your chance to make a significant impact while growing your career in CSV consulting. Why Choose Rephine? Competitive Compensation: A salary that reflects your experience, along with additional vacation days and other benefits. Work‑Life Balance: Hybrid work model, flexible hours, and a shorter workday on Fridays. Global Exposure: Work with a multicultural team across multiple countries. Dynamic Work Environment: Join a young, enthusiastic team where your contributions are valued and ideas shape the future. Flexible Salary Options: Salary sacrifice schemes and more flexibility. Opportunities for Growth: Nurturing environment for career advancement. Drive Digital Transformation: Participate in projects with latest technologies. For over 20 years, Rephine has been at the forefront of improving manufacturing quality processes for leading Life Sciences companies. We’re evolving rapidly and looking for passionate professionals eager to grow with us. Ready to embark on this journey? Visit our career site to learn more and apply in English. Amaris Consulting – Validation Specialist (Test QA) Take your career to the next level with Amaris Consulting as a Validation Specialist (Test QA). Become part of an international team, thrive in a global group with €800M turnover and 1,000+ clients worldwide, and an agile environment by planning the kickoff and follow up on projects. Join Amaris Consulting, where you can develop your potential and make a difference within the company. +3 years of senior experience in IT validation within GxP environments. Proven expertise in Veeva Conformance and Validation Testing and W3C Validation. Strong knowledge of pharma industry regulations and GxP compliance. Experience with LEVA system life cycle documentation (VP, URS, FS, RA, Testing Reports, AAP). Degree in Business Administration, Computer Science or comparable professional experience. English fluency and Spanish as mother tongue is highly valued. WHAT WILL YOU DO? Lead validation activities for global testing applications (BI-AS-ODIN, BI-IT-INMATION). Ensure compliance with validation planning and applicable BI standards before system operation. Develop and maintain system‑specific SOPs and SLC documentation. Manage validation status throughout system lifecycle and post‑operation phases. Create and deliver training on Standard Operating Procedures as defined in Validation Plans. Coordinate with IT Operations & Laboratories teams on Manufacturing Connectivity projects. QbD Group – Computer System Validation (CSV) Specialist QbD Group’s team offers knowledge & tailored (software) solutions in development, clinical, regulatory & compliance, production and distribution for companies active in Pharma, ATMP and Medical Devices/IVD. We are always looking for the next QbD’er in Software Solutions. What’s in it for you? Make a real impact: Contribute to shaping the future of the Life Sciences industry by supporting innovative projects and clients across pharma, biotech and medical devices. Grow within a community of experts: Benefit from knowledge‑sharing, mentoring, and exposure to diverse, challenging assignments that broaden your expertise. Build a meaningful career: As an ambitious and pioneering company, we want to offer you the best possible environment to thrive within the life sciences. A fair, competitive package: We offer tailored, transparent compensation aligned with your expertise, preferences, and local market regulations — because your contribution deserves to be valued. What you’ll be doing Automated systems Software as a Medical Device (SaMD) Mobile apps From preparation and project design to implementation and follow‑up, you will provide full‑cycle support to clients, ensuring the successful delivery of projects. You will also contribute to the integration and implementation of our proprietary QbD quality management software at client sites. With your knowledge of data integrity and quality management, you will support companies across the Life Sciences, including pharmaceuticals, biotech, medical devices and healthcare—from large, established firms to the most innovative start‑ups. What you bring You hold a master’s degree in a scientific or engineering field (e.g., bio‑engineering, bioinformatics, industrial engineering, civil engineering, etc.). You have some experience in the Life Sciences industry or with software‑related projects. You have a strong affinity with IT, software, and systems. You have knowledge of data integrity. You are detail‑oriented, eager to learn, and adaptable to new challenges. You possess strong technical and project management skills. You are responsible, with a strong analytical mindset and excellent problem‑solving abilities. DFT & Post‑Silicon Validation Engineer – Semiconductor Company Develop and implement DFT (Design for Testability) methodologies for complex digital designs. Work on scan insertion, ATPG, and test coverage analysis. Develop and execute validation plans to ensure functionality and performance. Analyze silicon test results and debug issues across hardware and system levels. Collaborate with RTL, verification, and physical design teams to improve testability and quality. Contribute to continuous improvement of validation and testing methodologies. Bachelor’s, Master’s, or PhD in Electrical Engineering, Computer Engineering, or a related field. Strong knowledge of DFT methodologies (scan, ATPG, test coverage). English level C1 or higher. Knowledge of high‑performance or AI processor architectures. Experience with Python, TCL, or scripting for automation. Relocation package for you and your family (visa, flight, first month rent, housing assistance). Permanent, full‑time onsite role in Barcelona, Spain. Flexible working hours (9–6, Monday to Friday). Work in one of the very few companies in Europe building AI chip infrastructure. PQE Group – Cleaning Validation Specialist Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas. We are seeking a Cleaning Validation Specialist to support cleaning validation activities within a GMP‑regulated pharmaceutical manufacturing environment. Responsibilities include, but are not limited to: Support the planning and execution of cleaning validation activities for manufacturing equipment and facilities. Assist in the preparation and review of validation protocols and reports. Participate in sampling activities and support analysis of validation data. Collaborate with Manufacturing, Quality Assurance, and Engineering teams to ensure compliance with GMP requirements. Support risk assessments and validation strategies related to equipment cleaning processes. Contribute to investigations, deviations, and CAPA actions associated with cleaning validation. Maintain and organize validation documentation according to regulatory and internal quality standards. Assist in preparing documentation for internal audits and regulatory inspections. Required Qualifications: Bachelor’s or Master’s degree in Pharmaceutical Sciences, Biotechnology, Chemistry, Chemical Engineering, or Life Sciences. Minimum 1 year of experience in the pharmaceutical, biotechnology, or related regulated industry (internships or academic projects are also considered). Basic understanding of GMP principles and pharmaceutical manufacturing environments. Strong attention to detail and good analytical skills. Ability to work collaboratively in cross‑functional teams. Fluent in English and Spanish. Next Steps: Upon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. If there's a positive match, a technical interview with the Hiring Manager will be arranged. In the case of a positive outcome from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. Alternatively, if the outcome is negative, we will contact you to halt the recruitment process. Working at PQE Group: As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. Apply now and take the first step towards an amazing future with us. #J-18808-Ljbffr