Quality Engineer — Pharmaceutical Manufacturing, UK (Contract)

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.