R&D Computer Systems Validation specialist
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Job Location:
Monthly Salary:
Posted on:
20 hours ago
Vacancies:
1 Vacancy
Job Summary
Job Description
We are seeking atemporaryCSV expert forourR&D teaminGlostrupDenmarkwhich is part of Pathology R&D in ourLife Sciences and Diagnostics Markets Group. Weare introducinga number ofnew systems tosupportdevelopmentofourhigh-quality portfolio of pathology stainingsolutionsfor cancerdiagnostics andwould like to ensure successful implementation of these.
The CSVexpertensures compliance with Agilents Quality Management System (QMS) and regulatory requirements by guiding and supporting Computer System Validation (CSV) activities across multiple business processes and systemswithin Pathology R&D.
The job and your responsibilities:
AsR&DComputer Systems Validation specialistyou will work withdifferentteamsto drive activities and projects related to ourR&D processes and tools. Our processes for CSV have recently changed and your job will be to spearhead our CSV efforts. You will work together with R&D business owners specialists external vendors internaldevelopersand Agilent IT.
Your tasks will include:
CSV Process Leadership:
Act as the primary point of contact for CSV activities across different business process owners and system ownerswithin Pathology R&D.
Ensure adherence toAgilentComputer System Validation SOP.
Guidance and Support:
Provide expert advice on CSV lifecycle phases (Initiation Define Design Build Test Deploy Stabilize Retirement).
Assist(or act as)system owner(s)in preparing validation documentation (e.g. Master Validation PlanRequirements SpecificationsRisk Assessment Test Protocols).
Compliance and Documentation:
Maintain accurate records in accordance with Agilent QMS and regulatory standards (ISO13485 FDA EU IVDR).
Ensure proper archiving and retrieval of validation evidence.
Training and Awareness:
Conduct or coordinate training sessions for stakeholders on CSV processes and tools (e.g. JIRASparkflowAzureHPALM Polarion).
Continuous Improvement:
Identify process gaps and propose improvements for CSV efficiency and compliance.
Qualifications
We are looking for a motivated individual with the following background:
Bachelors degree in Engineering Computer Science Quality Management or related field.
Proven experience in Computer System Validation within a regulated environment (medical devices pharma or similar).
Strong knowledge ofGxPrequirements and risk-based validation approaches.
Familiarity with tools such as JIRA HP-ALM Polarion and Agile methodologies.
Excellent English verbal/written communications skills
On a personal level you are rigorous driven and process oriented. You also have excellent interpersonal and communication skills to interact with many external and internal partners. You enjoy working both autonomously and as part of a team. Whilst being flexible and adaptable you have also strong planning organizational and time management skills.
We offer:
Outstanding company culture
Many opportunities for personal career andexpertisedevelopment
A position within an international organization offering a dynamic working environment with exciting challenges and opportunities
Company pension scheme individual bonus plan private health care medical & life insurance
Questions:
For any questions please contactthe hiring manager Jens Ole Madsenviaemailat.
Application:
We will review applicationscontinuouslyso please send us your CV and cover letter as soon as possible via our recruitment system. We are looking forward to hearing from you.
About Agilent:
Agilent inspires and supports discoveries that advance the quality of life. We provide life science diagnostic and applied chemical market laboratories worldwide with instruments services consumablesapplicationsandexpertise. Agilent enables customers to gain the answers and insights theyseek- so they can do what they do best: improve the world around us. Information about Agilent is available at.
Additional Details
This job has a full time weekly schedule.Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity national origin protected veteran status disability or any other protected categories under all applicable laws.Travel Required:
OccasionalShift:
DayDuration:
Over 12 MonthsJob Function:
R&DRequired Experience:
IC
Key Skills
- Laboratory Experience
- Vendor Management
- Design Controls
- C/C++
- FDA Regulations
- Intellectual Property Law
- ISO 13485
- Research Experience
- SolidWorks
- Research & Development
- Internet Of Things
- Product Development
