At a Glance
- Tasks: Lead process validation and support new product transfers in a dynamic pharmaceutical environment.
- Company: Join a growing pharmaceutical manufacturing organisation with a focus on innovation.
- Benefits: Full-time, permanent role with competitive salary and career growth opportunities.
- Other info: Collaborative culture with a focus on continuous improvement and compliance.
- Why this job: Make a real impact in the pharmaceutical industry while working with cutting-edge technologies.
- Qualifications: Degree in Science, Pharmaceutical or Engineering; experience in GMP-regulated environments.
The predicted salary is between 38250 - 46750 £ per year.
Technical Operations Lead
Location
Northern Ireland
Type
Full Time, Permanent
The Opportunity
We are seeking an experienced
Technical Operations Lead to join a growing pharmaceutical manufacturing organisation.
This is a key technical role supporting the transfer of new products into commercial manufacturing, while also providing ongoing lifecycle support for established products.
The successful candidate will bring strong expertise in process validation, technology transfer, GMP compliance, and manufacturing support , working cross-functionally across Pharmaceutical Development, Technical Services, Engineering, Quality, Regulatory Affairs and Manufacturing Operations.
Key Responsibilities
- Lead and support process validation activities across development and commercial manufacturing programmes.
- Prepare, review and approve validation protocols, reports, SOPs, master plans and supporting technical documentation.
- Collaborate with Process Development, Technical Services, Engineering, Health & Safety and Quality teams to establish robust process control strategies.
- Support equipment qualification activities, process performance qualification (PPQ) studies and associated risk assessments.
- Review manufacturing process documentation to ensure alignment with approved formulations and regulatory submissions.
- Provide technical expertise during investigations relating to deviations, CAPAs, out-of-specification (OOS) and out-of-trend (OOT) results.
- Support the introduction of new products into manufacturing and provide technical oversight throughout technology transfer activities.
• Act as a subject matter expert for validation activities, including
- Manufacturing process validation
- Packaging process validation
- Cleaning validation
- Equipment qualification
- Facility and computerised system validation
- Provide technical support to Regulatory Affairs on validation-related matters.
- Participate in project and customer meetings to ensure projects remain aligned with agreed timelines and objectives.
- Support scale-up activities from development through to commercial manufacture.
- Identify and implement continuous improvement initiatives focused on process efficiency, yield improvement, cycle time reduction and cost optimisation.
- Ensure all activities are conducted in compliance with current GMP requirements, EHS standards and applicable regulatory expectations.
- Maintain awareness of current international regulatory guidance and industry best practices relating to process validation.
Essential Requirements
- Degree qualified in a Scientific, Pharmaceutical, Engineering or related discipline.
- Experience working within a GMP-regulated pharmaceutical or life sciences environment.
- Practical experience of process validation and associated regulatory requirements.
- Experience authoring and reviewing technical documentation, including protocols and reports.
- Strong understanding of data interpretation, investigation processes and risk-based decision making.
- Working knowledge of VICH guidelines.
- Proficient in Microsoft Office applications.
Desirable Requirements
- Process Engineering or Chemical Engineering background.
- Experience supporting technology transfer and scale-up activities.
- Previous experience transferring products from development into commercial manufacture.
- Experience across multiple pharmaceutical dosage forms.
- Additional experience within pharmaceutical development, technical services or manufacturing support functions.
- Additional Information
- This manufacturing facility handles penicillin products. Therefore, the role may not be suitable for individuals with a penicillin allergy.
- Applicants must have the right to work in the UK at the time of application.
Locations
Technical Operations Lead in Cheshire, Warrington employer: Next Phase Recruitment
Join a dynamic pharmaceutical manufacturing organisation in Northern Ireland, where we prioritise employee growth and development within a collaborative work culture. As a Technical Operations Lead, you will benefit from a supportive environment that encourages innovation and continuous improvement, while also enjoying competitive remuneration and comprehensive benefits. Our commitment to GMP compliance and regulatory excellence ensures that you will be part of a team dedicated to making a meaningful impact in the industry.
StudySmarter Expert Advice🤫
We think this is how you could land Technical Operations Lead in Cheshire, Warrington
✨Unlock Networking Opportunities
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We think you need these skills to ace Technical Operations Lead in Cheshire, Warrington
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 Next Phase Recruitment!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Next Phase Recruitment that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Next Phase Recruitment!
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 Next Phase Recruitment, 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 Next Phase Recruitment
✨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 Next Phase Recruitment that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
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 Next Phase Recruitment’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.
✨Be Ready for Regulatory Scenarios
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.
