Job Description

Join our Engineering team as a Validation Engineer at our Haverhill manufacturing site to play a key role in planning, executing, and documenting validation activities to ensure compliance with regulatory requirements and internal quality standards. This includes equipment qualification, process validation, cleaning validation, and computer system validation.

Your Responsibilities

You will:

Define validation requirements for procurement enquiries. Perform risk assessments and gap analyses to identify validation needs at system and Component level (SIA/CIA). Develop and execute equipment purchase related validation documentation. (Pre delivery inspection, FAT, receipt verification and SAT protocols and reports) Develop and execute commissioning and validation protocols (OCD, IQ, OQ) for equipment, utilities, and processes in conjunction with the engineering team. Support CSV activities including Gamp lifecycle- based approach management Ensure validation activities comply with cGMP, FDA, EMA, and other regulatory guidelines. Collaborate with cross-functional teams including Quality Assurance, Production, Engineering, and IT. Support audits and inspections by providing validation documentation and expertise. Maintain accurate and complete validation documentation and reports. Participate in continuous improvement initiatives related to validation and compliance.

Our Requirements

Bachelor's Degree in Engineering, Life Sciences, or a related field. Proven experience in validation within a pharmaceutical or biotech manufacturing environment. Strong knowledge of cGMP, FDA, EMA, and ICH guidelines. Experience with validation of manufacturing equipment, cleanrooms, utilities (e.g., HVAC, WFI), and computerized systems. Excellent documentation and technical writing skills. Strong analytical and problem-solving abilities. Ability to work independently and in a team-oriented environment. Excellent communication skills.

Your Benefits

Attractive Salary Competitive benefits Training & Development Open and friendly working environment

Culture & Values

We bring our culture to life in the way we work every day. Our culture enables career development and talent management, we recognise that how we do things is as important as what we do, and our values set out how we achieve our goals and help us "do it right".

Diversity & Inclusion

We are committed to nurturing a culture of diversity and inclusion that contributes to improving innovation, performance, and engagement. We value transparency, mutual respect, and equal treatment of people. For this reason, we are firm in protecting our employees against any forms of discrimination.

We are Disability Confident - Committed

which means we make reasonable adjustments to our process and offer interviews to disabled people who meet the minimum criteria for our vacancies. If you would like any assistance or require the application to be completed in a different format, please call or contact our Haverhill site reception.

Environment, Social and Governance

We strongly believe that the success of our company lies in its capacity to adapt to tomorrow's challenges. Our responsibility as a company is to provide sustainability and resilience to the pharmaceutical value chain.

EUROAPI UK Limited (now part of Particle Dynamics)

Website

: https://particledynamics.com/

Apply Today!

Find out more about this exciting opportunity, apply today or contact Marie Meekings.