IT Validation Consultant – LIMS (Bioanalytical/Clinical Research)

Skills: QA, LIMS, SampleManager, CSV, GAMP 5, GxP
UK London & Halfax- Hybrid (3 days onsite & 2 days remote)
ASAP

 

We are seeking an experienced IT Validation Consultant to lead and support the validation of Laboratory Information Management Systems (LIMS) used in bioanalytical and clinical research environments. This role is instrumental in ensuring system compliance with global regulatory standards including FDA, EMA, MHRA, and other applicable authorities.

The successful candidate will have hands-on experience with LIMS platforms, particularly SampleManager within a regulated GxP environment and possess a solid understanding of validation best practices, data integrity, and system lifecycle management.

 

The Role:

Lead and execute validation activities for LIMS systems, including SampleManager. Plan, author, and execute validation deliverables such as IQ, OQ, PQ protocols and 21 CFR Part 11 compliance assessments. Develop and review documentation including Validation Plans, URS, FRS, Risk Assessments, Traceability Matrix, and Summary Reports. Ensure LIMS and associated systems meet GAMP 5, GxP, and ALCOA+ standards. Collaborate with cross-functional teams (QA, IT, Lab, Clinical) to gather requirements and assess risks. Support change control, periodic reviews, and system upgrades from a validation perspective. Assist during audits/inspections by preparing validation packages and addressing findings. Evaluate audit trails, data integrity controls, and electronic signatures for compliance. Provide guidance and training on validation and compliance best practices.

 

 What you will bring:

Bachelor’s or master’s degree in Life Sciences, Computer Science, IT, or a related field. Minimum of 3+ years of hands-on experience in IT Validation/CSV within regulated life sciences environments. Proven experience validating LIMS systems in bioanalytical or clinical research settings. In-depth knowledge of 21 CFR Part 11, EU Annex 11, GAMP 5, ICH E6(R2), and data integrity principles (ALCOA+). Experience with bioanalytical workflows, sample tracking, and LIMS data structures. Strong documentation and stakeholder communication skills. Experience working within CROs, clinical research, or pharmaceutical/biotech organizations. Familiarity with PK, TK, and biomarker lab processes. Experience integrating LIMS with systems like CDS, ELN, CTMS. Professional certifications in validation or QA are an advantage.

 

Hurry & apply for a more detailed conversation!

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