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Role: System Validation, Platform Qualification Location: Spain(100% Remote) Client: Infosys Sal: Market Range Permanent full-time position Requirements and number of open positions 3-5 years- 2 Positions in Open 5-10 Years- 2 Positions in Open 10+ years - 2 Positins in Open Role Overview We are looking for a highly experienced Validation resource with 10+ years of experience in Computerized System Validation (CSV) within the Life Sciences domain. The candidate will lead end-to-end validation activities for enterprise-level software systems and manage teams, stakeholders, and delivery for global programs. Key Responsibilities • Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review), • Drive validation strategy for enterprise programs across regions (Europe/Global), • Manage validation teams, allocate work, and ensure timely delivery, • Act as primary point of contact for client stakeholders and leadership, • Lead governance, status reporting, and escalation management, • Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report), • Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), • Manage quality processes (Deviation, CAPA, Change Control), • Support regulatory audits and inspection readiness, • Mentor and coach junior resources, build capability within the team, • Drive continuous improvement and standardization of validation processes Managerial Skills • Team leadership and people management, • Stakeholder and client relationship management, • Program and project management for global validation initiatives, • Risk and issue management with mitigation planning, • Resource planning and capacity management, • Governance, reporting, and executive communication, • Budget awareness and delivery management, • Cross-functional coordination across IT, QA, Business and Vendors Required Skills & Competencies • 10+ years of experience in Life Sciences CSV/CSA, • Exposure to cloud/SaaS validation, • Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.), • understanding of SDLC and validation lifecycle, • Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.), • Experience in risk-based validation and CSA approach, • Experience working with US and European clients and regulated environments, • Strong documentation, communication, and leadership skills.

Role: System Validation, Platform Qualification Location: Spain(100% Remote) Client: Infosys Sal: Market Range Permanent full-time position Requirements and number of open positions 3-5 years- 2 Positions in Open 5-10 Years- 2 Positions in Open 10+ years - 2 Positins in Open Role Overview We are looking for a highly experienced Validation resource with 10+ years of experience in Computerized System Validation (CSV) within the Life Sciences domain. The candidate will lead end-to-end validation activities for enterprise-level software systems and manage teams, stakeholders, and delivery for global programs. Key Responsibilities • Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review), • Drive validation strategy for enterprise programs across regions (Europe/Global), • Manage validation teams, allocate work, and ensure timely delivery, • Act as primary point of contact for client stakeholders and leadership, • Lead governance, status reporting, and escalation management, • Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report), • Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), • Manage quality processes (Deviation, CAPA, Change Control), • Support regulatory audits and inspection readiness, • Mentor and coach junior resources, build capability within the team, • Drive continuous improvement and standardization of validation processes Managerial Skills • Team leadership and people management, • Stakeholder and client relationship management, • Program and project management for global validation initiatives, • Risk and issue management with mitigation planning, • Resource planning and capacity management, • Governance, reporting, and executive communication, • Budget awareness and delivery management, • Cross-functional coordination across IT, QA, Business and Vendors Required Skills & Competencies • 10+ years of experience in Life Sciences CSV/CSA, • Exposure to cloud/SaaS validation, • Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.), • understanding of SDLC and validation lifecycle, • Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.), • Experience in risk-based validation and CSA approach, • Experience working with US and European clients and regulated environments, • Strong documentation, communication, and leadership skills.

Role: System Validation, Platform Qualification Location: Spain(100% Remote) Client: Infosys Sal: Market Range Permanent full-time position Descubra si esta oportunidad es adecuada para usted leyendo toda la información que sigue a continuación. Requirements and number of open positions 3-5 years- 2 Positions in Open 5-10 Years- 2 Positions in Open 10+ years - 2 Positins in Open Role Overview We are looking for a highly experienced Validation resource with 10+ years of experience in Computerized System Validation (CSV) within the Life Sciences domain. The candidate will lead end-to-end validation activities for enterprise-level software systems and manage teams, stakeholders, and delivery for global programs. Key Responsibilities • Lead end-to-end validation lifecycle (Planning, Risk Assessment, Testing, Release, Periodic Review), • Drive validation strategy for enterprise programs across regions (Europe/Global), • Manage validation teams, allocate work, and ensure timely delivery, • Act as primary point of contact for client stakeholders and leadership, • Lead governance, status reporting, and escalation management, • Author and review validation deliverables (URS, FRS, IQ/OQ/PQ, RTM, Validation Report), • Ensure compliance with 21 CFR Part 11, EU Annex 11, Data Integrity (ALCOA+), • Manage quality processes (Deviation, CAPA, Change Control), • Support regulatory audits and inspection readiness, • Mentor and coach junior resources, build capability within the team, • Drive continuous improvement and standardization of validation processes Managerial Skills • Team leadership and people management, • Stakeholder and client relationship management, • Program and project management for global validation initiatives, • Risk and issue management with mitigation planning, • Resource planning and capacity management, • Governance, reporting, and executive communication, • Budget awareness and delivery management, • Cross-functional xkdbapo coordination across IT, QA, Business and Vendors Required Skills & Competencies • 10+ years of experience in Life Sciences CSV/CSA, • Exposure to cloud/SaaS validation, • Strong experience in enterprise systems (SAP S/4HANA, Veeva Vault, LIMS, QMS etc.), • understanding of SDLC and validation lifecycle, • Understanding on regulatory guidelines (GAMP 5, GxP, 21 CFR Part 11, EU Annex 11 etc.), • Experience in risk-based validation and CSA approach, • Experience working with US and European clients and regulated environments, • Strong documentation, communication, and leadership skills.

ph3Overview /h3pAre you ready to join a bworld leader /b 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 b40 subsidiaries /b and more than b2000 employees in Europe, Asia and the Americas. /b /ppWe are currently seeking an bexperienced /b bCommissioning, Qualification Validation (CQV) Consultant /b in bMurcia, Spain /b. This role will focus on the bqualification /b and bvalidation /b of bequipment /b and bsystems /b in bbiotechnological production facilities /b. /ph3Responsibilities /h3ullibExecute commissioning, qualification, and validation activities /b for bpharmaceutical/biotech equipment /b and bsystems /b. /liliPrepare, review, and bexecute CQ and validation documentation /b (bURS, DQ, IQ, OQ, PQ protocols /b, btest scripts /b, and bsummary reports /b). /lilibCollaborate /b with bcross-functional teams /b (bEngineering, QA, Validation, Manufacturing /b) to ensure bcompliance /b with bGMP /b, bregulatory guidelines /b, and bproject timelines /b. /liliReview btechnical documentation /b, bPIDs /b, bFAT/SAT protocols /b, and bvendor manuals /b. /liliIdentify, btroubleshoot /b, and bdocument deviations /b, ensuring btimely resolution /b. /liliEnsure all activities meet bGMP /b, bFDA /b, bEMA /b, and bICH requirements /b. /liliProvide bproject updates /b and bprogress reports /b to bstakeholders /b. /li /ulh3Required Qualifications /h3ullibBachelor’s degree /b in bEngineering, Life Sciences /b, or related field. /lilibAt least 1 year of experience /b in bIQ/OQ/PQ protocol development /b and bexecution and CQ /b for pharmaceutical/biotech facilities, including construction of production plants /liliStrong knowledge of bGMP /b, bFDA /b, and bEU regulations /b. /liliExcellent banalytical /b, bproblem-solving /b, and bcommunication skills /b. /liliAbility to work bindependently /b and bcollaboratively /b in a bproject environment /b. /lilibSpanish native, English fluent (at least B2) /b /li /ulh3Next Steps /h3pUpon receiving your application, if a match is found, the Recruiting department will contact you for an initial HR interview. /ppIf there is a positive match, a technical interview with the Hiring Manager will be arranged. /ppIn the case of a positive outcome coming from Hiring Manager interview, recruiter will contact you for further steps or to discuss our proposal. /ppAlternatively, if the outcome is negative, we will contact you to halt the recruitment process. /ph3Working at PQE Group /h3pAs a member of the PQE team, you will be part of a bchallenging, multicultural company that values collaboration and innovation /b. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. /ppIf you are looking for a rewarding and exciting career, PQE Group is the perfect place for you. /ppApply now and take the first step towards an amazing future with us. /p /p #J-18808-Ljbffr

pTerry Soot Management Group is seeking field data collectors in Spain to support a EU-wide project. You will drive on designated routes, operate 360° cameras, and capture street-level visuals for a leading online mapping platform. /ppThe role requires a valid EU driver’s license, English and Spanish proficiency, and reliable, travel-ready candidates who can work full-time during standard business hours in some locations across Europe. /p #J-18808-Ljbffr

Company Description Si cree que es el candidato ideal para la siguiente oportunidad, envíe su solicitud después de leer la descripción completa. Terry Soot Management Group (TSMG) is a field data collection company founded in 2017 in Europe. We collect data where automation is not possible. We count features, take pictures, make videos, record speech, and scan areas for every detail you need to make more informed decisions. Our field data collection teams are spread across Europe and North America, ready to accept new challenges. Project Overview This project aims to collect high-quality visuals of streets, key points of interest, and public spaces across EU countries. Using vehicles equipped with removable 360° cameras and lidars, drivers will capture comprehensive images of the surroundings. The captured data will be stored on onboard computers (SSD Drives) and later utilized to enhance one of the world’s leading online mapping platforms. Data collectors will follow pre-assigned routes, focusing on public streets, commercial areas, and points of interest. To ensure the highest image quality, certain areas may need to be revisited during favorable weather conditions. The duration of the project varies based on the scope of work required in each targeted data collection area. On average, the assignments involve 3 to 6 months of active work. Work schedule Full time engagement within standard business hours (8 AM - 7 PM). Recruitment process Safety driving test, interview with recruiter, and onboarding process. Ideal Candidate • Holds a valid EU‑issued driver’s license, • Maintains a clean background check (criminal and driving record), • Has at least 5 years of driving experience, • Possesses professional driving experience (e.g., taxi, delivery, logistics), • Proficient in English and the local language, • Tech‑savvy, with experience using GSuite tools (Gmail, Google Spreadsheets, Google Forms), • Basic knowledge of vehicle mechanics, • Demonstrates responsibility, reliability, and professionalism, • Enjoys traveling and exploring new places, • Familiar with the area of operations What We Offer • A dynamic and engaging project that goes beyond just driving, • Competitive salary, • Comprehensive training covering both practical and theoretical aspects of data collection, • Ongoing support from experienced managers, • The opportunity to work in an international team and environment If you’re interested, apply now and join us in shaping the future of data collection! We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. xcskxlj Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us. #J-18808-Ljbffr