Process Validation Engineer

EPM Scientific; Fraga; Híbrido; EUR 42.000 - 64.000; Jornada completa

Descripción de la vacante

EPM Scientific seeks a Validation Engineer to support a high-volume injection moulding program in a hybrid-framed environment in Fraga, Spain. The role focuses on validating new and existing moulding processes and driving robust manufacturing standards across production operations.

Responsibilities include leading IQ/OQ/PQ activities, DOE-driven process development, data analysis, and preparation of validation documentation, reports and assessments, with close collaboration to manufacturing and

Formación

• Proven experience as Validation Engineer or Process Engineer in a regulated manufacturing environment.
• Strong background in Injection Moulding Process Validation.
• Hands-on experience executing IQ/OQ/PQ protocols.
• Experience with DOE and process development methodologies.
• Ability to independently manage validation documentation and technical reports.
• Strong stakeholder management and communication skills.

Responsabilidades

• Lead and execute process validation activities within an injection moulding environment.
• Develop and execute IQ, OQ and PQ protocols.
• Support Design of Experiments (DOE) activities to establish and optimise process windows.
• Perform process development and process characterisation activities.
• Generate validation documentation, reports and technical assessments.
• Collaborate with manufacturing, quality and engineering teams to support validation projects.
• Analyse process data and identify opportunities for process improvement.
• Support transfer, qualification and lifecycle management activities for moulding processes.

Conocimientos

Process Validation

IQ/OQ/PQ

DOE

Documentation

Stakeholder management

Descripción del empleo

Validation Engineer / Process Validation Engineer (Injection Moulding)

Location: Fraga, Spain
Contract Length: 6-12 Months (Potential Extension)
Hours: 40 Hours per Week
Working Pattern: Hybrid

Overview

We are seeking an experienced Validation Engineer to support a high-volume programme of process validation activities within an injection moulding manufacturing environment.

This position will play a key role in validating new and existing moulding processes, supporting process development activities, and ensuring robust manufacturing standards across critical production operations. The successful candidate will work closely with engineering and manufacturing teams to execute validation activities from process development through to final qualification.

Key Responsibilities

• Lead and execute process validation activities within an injection moulding environment.
• Develop and execute IQ, OQ and PQ protocols.
• Support Design of Experiments (DOE) activities to establish and optimise process windows.
• Perform process development and process characterisation activities.
• Generate validation documentation, reports and technical assessments.
• Collaborate with manufacturing, quality and engineering teams to support validation projects.
• Analyse process data and identify opportunities for process improvement.
• Support transfer, qualification and lifecycle management activities for moulding processes.

Required Experience

• Proven experience as a Validation Engineer or Process Engineer within a regulated manufacturing environment.
• Strong background in Injection Moulding Process Validation.
• Hands-on experience executing IQ/OQ/PQ protocols.
• Experience with Design of Experiments (DOE) and process development methodologies.
• Knowledge of process characterisation and establishing process windows.
• Ability to independently manage validation documentation and technical reports.
• Strong stakeholder management and communication skills.

Preferred Experience

• Medical device or pharmaceutical manufacturing experience.
• Mould design knowledge.
• Experience supporting mould transfers, tooling projects or capacity expansion initiatives.
• Broad understanding of injection moulding equipment and manufacturing processes.

Ideal Candidate

The ideal candidate will combine strong validation expertise with practical injection moulding process knowledge. Candidates who have actively developed, optimised and validated moulding processes will be particularly well suited to this opportunity. The ability to support both hands‑on process activities and validation documentation is highly desirable.