Experienced Quality Engineer, GMP Pharma Manufacturing

Myn; Greater London; On-site; GBP 50,000 - 75,000; Full time

Job summary

Myn is seeking a Quality Engineer to provide technical quality support across GMP manufacturing operations. The role focuses on equipment and process qualification, deviation investigation, CAPA management, and validation activities to ensure compliance and robust quality systems.

The ideal candidate has hands-on experience in a GMP environment, strong problem-solving skills, and the ability to contribute from day one through structured investigations and cross-functional collaboration.

Qualifications

• Degree in a relevant scientific or engineering discipline.
• Hands-on quality role in GMP pharmaceutical/biopharma/medical device manufacturing.
• Solid knowledge of EU GMP and HPRA requirements.
• Experience with deviation, CAPA, change control and root cause analysis.
• IQ/OQ/PQ documentation and execution experience.
• Available to start on short notice due to contract nature.

Responsibilities

• Support qualification activities for equipment, utilities, and processes (IQ/OQ/PQ).
• Investigate deviations using structured root cause methods and document findings.
• Author and track CAPAs through to closure.
• Assess quality impact of changes to processes or documentation.
• Review batch records and quality documents for GMP compliance.
• Assist audits and regulatory inspections with technical quality input.
• Conduct risk assessments (e.g., FMEA) for processes and equipment.
• Collaborate with Manufacturing, Engineering, Validation, and Regulatory Affairs.
• Maintain quality metrics and escalate emerging risks.

Skills

Quality engineering

Root cause analysis

CAPA implementation

IQ/OQ/PQ

GMP compliance

Deviation investigation

Regulatory knowledge

Data analysis

Risk assessment

Cross-functional collaboration

Education

Bachelor's degree in Chemistry, Biology, or related engineering/science

Tools

TrackWise

MasterControl

Veeva

Job description

Myn is seeking a Quality Engineer to provide technical quality support across GMP manufacturing operations. The role focuses on equipment and process qualification, deviation investigation, CAPA management, and validation activities to ensure compliance and robust quality systems.

The ideal candidate has hands-on experience in a GMP environment, strong problem-solving skills, and the ability to contribute from day one through structured investigations and cross-functional collaboration.