Role & seniority: Qualification & Validation SME / Validation Engineer (senior level)

Stack/tools: Qualification & Validation (Q&V) strategy; Computer System Validation (CSV); mechanical qualification; protocols; qualification reports; validation reports; general documentation management

Top 3 responsibilities

Define and lead the Q&V strategy for assigned projects; oversee end-to-end validation activities (CSV and mechanical QUAL)
Write, review, and maintain all related documents (protocols, qualification reports, validation reports)
Manage Q&V projects from initiation to closure, ensuring timelines, quality, and stakeholder alignment

Must-have skills

Degree or higher in a relevant field (e.g., Pharmaceutical Chemistry, QA/QM)
4–5 years of Qualification & Validation experience with strong CSV focus; manufacturing experience a plus
Ability to develop Q&V strategies, execute validations, and produce comprehensive documentation
Fluent in French (mandatory); good written English
Independent, quick ramp-up, effective stakeholder communication

Nice-to-haves

Direct manufacturing environment experience
Additional language skills or broader regulatory exposure
Location & work type: Mix of onsite and remote work; fast-paced, proactive environment; flexible/ hybrid setup

Full Description

Role Overview

We are currently looking for a Validation Engineer to join a leading pharmaceutical manufacturing environment to support key automation revamping projects. This is an exciting full-time opportunity for a proactive and experienced professional to collaborate with our client’s team and contribute to impactful projects that enhance process efficiency and compliance.

An ideal candidate will possess a strong background in Qualification & Validation activities, with the ability to operate autonomously and communicate effectively with stakeholders at all levels. The role requires a quick ramp-up and a flexible approach, including a mix of onsite and remote work, within a dynamic and fast-paced setting.

Key Duties And Responsibilities

Your duties as the Qualification & Validation SME will be varied however the key duties and responsibilities are as follows

Define and develop the Qualification & Validation (Q&V) strategy for assigned projects. Lead and execute qualification activities, including mechanical qualification and Computer System Validation (CSV). Write, review, and maintain all relevant documentation such as protocols, qualification reports, and validation reports. Manage Q&V projects from initiation through to closure, ensuring timelines and quality standards are met. Communicate and collaborate with project stakeholders to ensure alignment and project success. As the Qualification & Validation SME, you will take overall responsibility for validation deliverables and project execution.

Role Requirements

To be successful in your application to this exciting role as the Qualification & Validation SME we are looking to identify the following on your profile and past history

A Degree or higher level in a relevant field (e.g., Pharmaceutical Chemistry, Quality Assurance, Quality Management). Proven experience of 4–5 years in Qualification & Validation, with a strong emphasis on CSV; manufacturing experience is highly advantageous. Demonstrable ability to develop Q&V strategies, execute validation activities, and compile comprehensive documentation. Fluency in French (mandatory) and good written English skills. Ability to work independently with minimal onboarding, adapting quickly to project needs and environment.

Key Words: Qualification / Validation / CSV / Automation / Manufacturing / Validation Strategy / Stakeholder Communication / Pharmaceutical

"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."