Validation Engineer

TN United Kingdom; Sudbury; On-site; GBP 80,000 - 100,000; Full time

Job summary

An established industry player is looking for a Validation Engineer to join their multidisciplinary team. This role involves preparing, scheduling, and executing Commissioning, Qualification, and Validation protocols, ensuring compliance with regulatory requirements. The ideal candidate will have 5-7 years of experience in validation and quality systems, with a strong background in GMP validation disciplines. This position offers a unique opportunity to contribute to critical projects in the pharmaceutical sector, where your expertise will play a vital role in maintaining high standards of quality and safety in manufacturing processes. Join a dynamic team and make a significant impact in the industry.

Qualifications

• 5-7 Jahre Erfahrung in Validierung, Qualitätssystemen oder Ingenieurwesen.
• Erfahrung in GMP-Validierungsdisziplinen mit technischem Wissen.

Responsibilities

• Entwicklung und Ausführung von Validierungsprotokollen für Systeme.
• Leitung von Risikoanalysen für Prozesse und Ausrüstung.

Skills

Validation Engineering

Risk Assessment

Quality Systems

GMP Validation

Technical Knowledge

Education

BSc/MSc in Engineering

BEng/MEng in Engineering

Job description

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Job Description

A Validation Engineer is required by Careerwise recruitment to work with our Clare based pharmaceutical client.

Role of this position

1. Effectively working within a multidisciplinary team to prepare, schedule and execute Commissioning, Qualification and Validation protocols.
2. Lead Risk assessments for process and equipment as required.
3. Develop system impact assessments, validation plans, protocols and reports that support the qualification and validation of systems.
4. Execute Commissioning and validation of manufacturing equipment, downstream equipment and processes in addition to supervising and witnessing Validation / Qualification carried out by vendors.
5. Develop protocols for validation projects that meets regulatory requirements and industry practices.

JOB REQUIREMENTS

1. BSc/MSc or BEng/MEng in Engineering or related discipline.
2. 5 -7 years minimum in validation, quality systems, operations, engineering or any combination thereof.
3. Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
4. Validation experience using risk based approach guidelines, international regulatory requirements and standards.