Role Overview:
We are looking for an experienced GxP Validation Analyst to support a global Instrument Software Validation project covering approximately 200 unique lab instruments. The role will focus on documenting, validating, and aligning software installed on laboratory instrumentation in line with EMA guidelines, Annex 11, GAMP 4, and internal IT SOPs.
The ideal candidate will have strong experience in software validation within regulated pharmaceutical, biotech, or CRO environments, with the ability to work closely with Lab, IT, QA, and vendor stakeholders.
Key Responsibilities:
* Gather, analyze, and document user and system requirements, including URS and software configuration details.
* Prepare and maintain validation documentation for lab instrument software.
* Write, review, and execute validation test cases, including IQ, OQ, and PQ, where applicable.
* Support the preparation of requirements specifications, infrastructure diagrams, and data flow diagrams.
* Perform risk assessments and ensure full traceability from requirements to risks, tests, and results.
* Support migration of instrument software management processes to IT SOPs.
* Ensure validation activities are aligned with applicable regulatory and compliance requirements.
* Collaborate with laboratory, IT, QA, CSV, and vendor teams to clarify requirements and resolve validation issues.
* Maintain accurate validation records and support audit readiness.
* Communicate project status, risks, and documentation updates to relevant stakeholders.
Required Skills and Experience:
* Strong experience in software validation / computerized system validation in a GxP-regulated environment.
* Experience with lab instruments, laboratory systems, or instrument software validation.
* Good understanding of EMA guidelines, Annex 11, and GAMP 4.
* Strong technical writing and documentation skills.
* Ability to create or support infrastructure diagrams and data flow diagrams.
* Experience writing and executing validation test scripts, including IQ, OQ, and PQ.
* Ability to perform risk assessments and maintain traceability matrices.
* Strong attention to detail and ability to work in a structured, compliant environment.
* Excellent communication and stakeholder management skills.
* Ability to work effectively with Lab, IT, QA, and vendor teams.
Qualifications:
* Degree in Life Sciences, Computer Science, Engineering, or a related discipline.
* 6–9 years of relevant validation experience, preferably in pharma, biotech, CRO, or another regulated life sciences environment.
* Familiarity with CSA principles is considered a plus.
Nice to Have:
* Experience with large-scale/global validation projects.
* Previous involvement in SOP migration or alignment with IT governance processes.
* Experience validating software across multiple laboratory instruments.
* Knowledge of data integrity principles and audit readiness requirements.