Myn
Quality Engineer — Pharmaceutical Manufacturing, UK (Contract)
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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.
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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.
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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.
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