Validation Engineer for Innovative Fertility Diagnostics Company

Fixed term contract. 6-9 months.

ABOUT

We are recruiting for a fertility diagnostics company developing PCR-based testing solutions. With a focus on precision and regulatory rigour the business is building the validation infrastructure needed to bring its diagnostics platform to market under UK regulatory frameworks.

POSITION OVERVIEW
We are seeking a Validation Engineer on a fixed-term contract (69 months) to lead the writing and formalisation of the validation documentation suite. This is a primarily office-based documentation-focused role:
the scientific lead will run the experiments and the successful candidate will translate those results into fully compliant validation protocols and reports.
The ideal candidate will have a strong grasp of PCR-based diagnostic workflows ideally with experience in DDP and a track record of producing validation documentation to ISO 15189 ISO 13485 MHRA (IVDD/IVDR) and UKAS
standards.

At the end of the contract deliverables and knowledge will be handed over to the incoming Quality Manager.

CORE RESPONSIBILITIES
1. Validation Protocol Writing
Author comprehensive validation protocols and reports aligned to ISO 15189 ISO 13485 MHRA (IVDD/IVDR) and UKAS requirements
Work directly with the scientific lead to understand experimental design and translate results into formal documentation
Produce validation reports that may run to several hundred pages accuracy and regulatory alignment are paramount
2. Regulatory Compliance
Ensure all validation documentation meets applicable MHRA (IVDD/IVDR) regulations
Maintain awareness of evolving UK IVD regulatory requirements and apply them to documentation deliverables
Support preparation for UKAS accreditation activities as required
3. PCR Workflow Understanding
Apply working knowledge of PCR-based diagnostic workflows to contextualise and validate experimental data
Engage with DDP (Droplet Digital PCR) workflows where relevant to the validation programme
Liaise with laboratory scientists to ensure technical accuracy of all written outputs
4. Handover & Knowledge Transfer
Structure validation documentation for long-term maintainability and ease of handover
Deliver a clean complete handover package to the incoming Quality Manager at contract end
Document processes and decisions to support continuity of the quality function

REQUIRED QUALIFICATIONS & EXPERIENCE

Background in molecular biology or a closely related life science discipline

Hands-on experience in a diagnostic laboratory environment
Proven track record writing validation protocols and reports for IVD products
Strong working knowledge of ISO 15189 ISO 13485 MHRA IVDD/IVDR and UKAS standards
Experience with PCR-based diagnostic workflows; DDP experience is advantageous
Excellent written communication skills this is primarily a documentation role
Ability to work independently and manage workload across a hybrid schedule

Available for a fixed-term engagement of 69 months