Validation Engineer

CareerWise Recruitment; Sudbury; On-site; GBP 40,000 - 60,000; Full time

Job summary

A leading company in the pharmaceutical sector is seeking a Validation Engineer to collaborate within a multidisciplinary team. The successful candidate will be responsible for executing validation protocols, leading risk assessments, and ensuring compliance with regulatory standards. Candidates should have a relevant degree and substantial experience in GMP validation disciplines, alongside a strong technical understanding. This is a key role that supports the qualification of advanced manufacturing systems.

Qualifications

• Minimum of 5-7 years experience in validation or related field.
• Experience in multiple GMP validation disciplines.
• Validation experience using risk-based approach guidelines.

Responsibilities

• Prepare, schedule, and execute Commissioning, Qualification, and Validation protocols.
• Lead risk assessments for process and equipment.
• Supervise and witness validation carried out by vendors.

Skills

Risk assessment

Regulatory compliance

GMP validation

Technical knowledge

Education

BSc/MSc or BEng/MEng in Engineering or related discipline

Job description

Social network you want to login/join with:

Job Description

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

Role of this position

• Effectively work within a multidisciplinary team to prepare, schedule, and execute Commissioning, Qualification, and Validation protocols.
• Lead risk assessments for process and equipment as required.
• Develop system impact assessments, validation plans, protocols, and reports to support the qualification and validation of systems.
• Execute commissioning and validation of manufacturing equipment, downstream equipment, and processes, as well as supervise and witness validation/qualification carried out by vendors.
• Develop protocols for validation projects that meet regulatory requirements and industry practices.

Job Requirements

• BSc/MSc or BEng/MEng in Engineering or related discipline.
• Minimum of 5-7 years in validation, quality systems, operations, engineering, or a related field.
• Experience in multiple GMP validation disciplines (process equipment, utility, automation, computer systems, sterilization) with advanced technical knowledge.
• Validation experience using risk-based approach guidelines, international regulatory requirements, standards, and other relevant guidelines.