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.
#J-18808-Ljbffr
Quality Engineer — Pharmaceutical Manufacturing, UK (Contract) in London employer: Myn
Myn is an exceptional employer, offering a nurturing and supportive work environment for Nursery Room Leaders in Bristol. With generous benefits such as 33 days of annual leave, flexible working options, and extensive family and wellbeing support, employees are encouraged to thrive both personally and professionally. The company prioritises employee growth through tailored training and progression opportunities, making it a rewarding place to build a meaningful career in early years education.
