At a Glance
- Tasks: Provide hands-on quality engineering support in pharmaceutical manufacturing.
- Company: Join a leading pharmaceutical company focused on quality and compliance.
- Benefits: Competitive pay, contract flexibility, and opportunities for professional growth.
- Other info: Fast-paced environment with a chance to work on diverse projects.
- Why this job: Make a real impact in ensuring product quality and safety in healthcare.
- Qualifications: Degree in science or engineering and experience in quality roles required.
The predicted salary is between 37800 - 46200 £ per year.
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. Track Wise, Master Control, 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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Quality Engineer — Pharmaceutical Manufacturing, UK (Contract) 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.
StudySmarter Expert Advice🤫
We think this is how you could land Quality Engineer — Pharmaceutical Manufacturing, UK (Contract)
✨Get Familiar with Temporary Roles in Pharma
Temporary positions in the pharmaceutical industry often arise during specific periods, like product launches or seasonal hiring sprints. Keep an eye on timelines and be proactive in reaching out to companies, especially around these busy times!
✨Join Pharma Networking Events
Participate in local and virtual pharmaceutical networking events or job fairs. This is a fantastic way to get in front of hiring managers and learn more about temporary opportunities directly from those in the know.
✨Leverage Your University Career Services
If you’re a student or recent grad, tap into your university’s career services which often have specific connections to pharma companies looking to fill temporary roles. They might even have exclusive internship programmes that lead to temp jobs!
✨Be Visible Online and Offline
Utilise platforms like LinkedIn to share your interests in temporary roles and connect with industry professionals. Plus, consider writing about relevant pharmaceutical topics to showcase your knowledge and enthusiasm—this can help you stand out to hiring companies like Myn.
We think you need these skills to ace Quality Engineer — Pharmaceutical Manufacturing, UK (Contract)
Some tips for your application 🫡
Highlight Your Relevant Experience:In the pharmaceutical industry, it's crucial to showcase any relevant experience you have, whether it's internships, lab work, or coursework. Let’s emphasise your familiarity with drug development processes and any hands-on experience you've had with lab equipment or clinical trials in your CV.
Mention Certifications and Training:If you’ve got any certifications relevant to pharmaceuticals, like Good Clinical Practice (GCP) or a certification in pharmacovigilance, make sure to include them. These show your commitment to the field and can make a positive impact on your application for a temporary role at Myn.
Show Your Flexibility and Availability:Temporary positions often require immediate availability and flexibility in working hours. In your cover letter, make it clear when you can start and your ability to adapt to changing schedules, as this is key to a successful application.
Express Your Learning Goals:Since this is a temporary role, we suggest discussing what you hope to learn or gain from the experience at Myn. This not only shows your eagerness but also helps employers see you as someone who’s ready to make the most out of the opportunity.
How to prepare for a job interview at Myn
✨Know Your Regulations
In the pharmaceutical industry, it’s crucial to understand key regulations like GMP (Good Manufacturing Practices) or GCP (Good Clinical Practices). Brush up on these standards and be ready to discuss how they influence your work approach during your interview with Myn.
✨Emphasise Adaptability
Since this is a temporary role, show that you're ready to hit the ground running. Share examples from your past experiences that demonstrate your ability to adapt quickly to new environments or changes, especially in a fast-paced setting like pharmaceuticals.
✨Highlight Relevant Skills and Tools
Whether it’s laboratory techniques or software like LabWare or SAS, make sure you can confidently talk about your technical skills. If you have experience with any specific tools used in previous roles, relate that directly to how it can help Myn achieve its goals.
✨Prepare for Technical Questions
Be ready for technical questions related to drug development processes or quality assurance. We should expect scenarios where you might have to troubleshoot a problem or suggest improvements on a project—this shows your problem-solving capability in a temporary role.
