At a Glance
- Tasks: Execute requalification activities for sterile manufacturing processes and ensure compliance with GMP standards.
- Company: Join a global Pharma Services organisation dedicated to life-saving therapies.
- Benefits: Competitive salary, shift allowance, and opportunities for professional growth.
- Other info: Dynamic team environment with opportunities for career advancement.
- Why this job: Make a real impact in the pharmaceutical industry while working with cutting-edge technology.
- Qualifications: Degree in engineering or related field; experience in GMP-regulated environments preferred.
The predicted salary is between 30000 - 40000 £ per year.
Work Schedule: Rotational M-F days
Environmental Conditions:
- Adherence to all Good Manufacturing Practices (GMP)
- Safety Standards
- Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed
- Cold Room/Freezers -22 degrees F/-6 degrees C
- Office
- Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
- Working at heights
About the Role:
This position sits within Manufacturing Engineering / Validation and focuses on maintaining the validated state of sterile fill/finish processes and supporting systems. You’ll be responsible for executing and managing process requalification activities, ensuring continued compliance with EU Annex 1, GMP standards, and site contamination control strategies. Your work will directly support operational readiness and ongoing manufacturing performance.
Key Responsibilities:
- Execute requalification activities for aseptic manufacturing processes and cleanroom environments
- Manage the requalification lifecycle, including periodic and event-driven activities
- Plan and document activities in line with approved protocols, maintaining inspection readiness
- Requalify temperature-controlled systems (e.g. freezers, cold rooms, incubators)
- Assess the impact of changes, deviations, and maintenance on validated state
- Author and review protocols, reports, and risk assessments
- Support regulatory inspections and audits
About You:
- Degree or equivalent in engineering, pharmaceutical sciences, biotechnology, or similar
- Experience in validation, requalification, or process qualification within a GMP-regulated pharmaceutical or biotechnology manufacturing environment
- Background in sterile or aseptic manufacturing is strongly preferred
- Good understanding of cGMP, data integrity, and regulatory expectations
- Able to manage multiple activities with a structured, detail-oriented approach
- Comfortable working in a regulated environment with a focus on quality and compliance
Why Join:
- Work within a technically focused engineering and validation team
- Contribute to maintaining robust, compliant manufacturing processes
- Opportunity to support complex sterile manufacturing operations in a regulated setting
- Be part of a site continuing to grow its capabilities and capacity
If you’re looking for a role where you can apply your technical expertise to maintain high standards in sterile manufacturing, we’d like to hear from you.
Competitive Package and Shift Allowance
Requalification Technician in Swindon employer: Dormont Manufacturing Co
Join a leading global Pharma Services organisation in Swindon, where you will be part of a dynamic team dedicated to developing life-saving therapies. Our commitment to employee growth is reflected in our supportive work culture, competitive packages, and opportunities to engage in complex sterile manufacturing operations. With a focus on compliance and quality, we provide a unique environment that fosters technical expertise and career advancement.
StudySmarter Expert Advice🤫
We think this is how you could land Requalification Technician in Swindon
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We think you need these skills to ace Requalification Technician in Swindon
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Dormont Manufacturing Co!
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Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Dormont Manufacturing Co, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Dormont Manufacturing Co
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Dormont Manufacturing Co that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
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If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Dormont Manufacturing Co’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
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In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
