Quality Engineer — Pharmaceutical Manufacturing, UK (Contract)

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

Role Overview

The successful candidate will provide technical quality engineering support across manufacturing operations, with a focus on equipment/process qualification, deviation investigation, CAPA, and validation activities. This is a hands-on, execution-focused role suited to an experienced Quality Engineer who can be effective quickly in a GMP manufacturing environment with minimal ramp-up time.

Role Overview

The successful candidate will provide technical quality engineering support across manufacturing operations, with a focus on equipment/process qualification, deviation investigation, CAPA, and validation activities. This is a hands-on, execution-focused role suited to an experienced Quality Engineer who can be effective quickly in a GMP manufacturing environment with minimal ramp-up time.

Key Responsibilities

• Support equipment, utility, and process qualification activities (IQ/OQ/PQ), ensuring documentation meets GMP and regulatory requirements.
• Investigate deviations and non-conformances, applying structured root cause analysis (e.g. 5 Whys, Fishbone/Ishikawa, FMEA) to identify true root cause.
• Author, implement, and track CAPAs (Corrective and Preventive Actions) through to effective closure.
• Support change control activities, assessing the quality impact of proposed changes to processes, equipment, or documentation.
• Review and approve batch records, protocols, and quality records, ensuring accuracy and GMP compliance.
• Support internal and external audits, including supplier quality audits and regulatory inspections, providing technical quality input as required.
• Conduct and document risk assessments (e.g. FMEA) for processes, equipment, and changes.
• Collaborate with Manufacturing, Engineering, Validation, and Regulatory Affairs to resolve quality issues and support continuous improvement.
• Maintain quality metrics and trend data, identifying and escalating emerging risks.
• Ensure all work is conducted in compliance with EU GMP, HPRA requirements, and site EHS standards.

Essential Qualifications & Experience

• Degree in a relevant scientific or engineering discipline (chemistry, biology, chemical/mechanical engineering, or related field).
• Demonstrable experience in a Quality Engineer or similar hands-on quality role within pharmaceutical, biopharmaceutical, or medical device manufacturing.
• Strong working knowledge of EU GMP and HPRA regulatory requirements.
• Practical experience with deviation/CAPA/change control systems and root cause analysis methodologies.
• Experience with equipment/process qualification (IQ/OQ/PQ) documentation and execution.
• Available to start within a short notice period, given the contract nature of the role.

Desirable Criteria

• Experience specific to the site's product type (e.g. sterile/aseptic manufacturing, biologics, oral solid dose, or combination products).
• Six Sigma / Lean qualification, or demonstrable continuous improvement project experience.
• Prior contract/interim experience, with the ability to add value quickly in an unfamiliar site environment.
• Experience with electronic QMS platforms (e.g. TrackWise, MasterControl, Veeva).
• Direct experience supporting HPRA or FDA regulatory inspections.

Person Specification

• Strong analytical and problem-solving skills, with a methodical approach to root cause investigation.
• Self-sufficient and effective from day one, able to integrate quickly into an established quality team.
• Excellent written communication skills, particularly for technical documentation and investigation reports.
• Detail-oriented, with a strong sense of ownership over quality outcomes.
• Collaborative team player, comfortable working cross-functionally with Manufacturing and Engineering colleagues.