At a Glance
- Tasks: Lead qualification and validation activities for cutting-edge pharmaceutical equipment.
- Company: Top-tier pharmaceutical manufacturer with a focus on innovation.
- Benefits: Long-term contract, competitive day rate, and collaborative team environment.
- Other info: Great opportunity for career growth and exposure to new technologies.
- Why this job: Make a real impact in the pharmaceutical industry while working on high-profile projects.
- Qualifications: Experience in equipment qualification and validation within GMP environments.
The predicted salary is between 40000 - 50000 £ per year.
Job Description
Your new company A leading pharmaceutical manufacturing organisation is seeking an experienced CQV / Validation Engineer to support a programme of new asset introduction and qualification activities within a GMP regulated environment.
Working alongside Engineering, Quality, Manufacturing and Project teams, you'll play a key role in ensuring critical equipment, facilities and utilities are introduced and maintained in a validated state.
Your new role As the Validation Engineer, you will be responsible for delivering qualification and validation activities across laboratory and manufacturing systems.
Key responsibilities will include: Authoring, reviewing and executing validation documentation including Validation Plans, Risk Assessments, IQ, OQ and PQ protocols and Validation Summary Reports.
Supporting new equipment introduction projects from planning through to GMP release.
Executing qualification activities for manufacturing and laboratory equipment.
Performing thermal mapping activities on controlled temperature units (CTUs), including fridges, freezers, incubators and other GMP systems.
Supporting qualification activities for equipment such as lyophilisers, sterilisers and associated utilities.
Conducting pre-calibration and post-calibration activities.
Managing deviations, investigations, CAPAs and change controls.
Analysing qualification data and producing technical reports.
Working closely with cross-functional stakeholders to deliver project milestones.
What you'll need to succeed Proven experience within pharmaceutical, biotechnology or life sciences manufacturing environments.
Strong background in equipment qualification and validation.
Experience authoring and executing IQ, OQ and PQ protocols.
Thermal mapping experience across controlled temperature units.
Knowledge of GMP, EU GMP and validation life cycle requirements.
Experience managing deviations, investigations and CAPAs.
Ability to generate and review validation documentation independently.
Excellent communication, technical writing and organisational skills.
Desirable experience: New asset introduction projects.
Lyophiliser qualification.
Sterilisation validation.
Utilities qualification (HVAC, WFI, Purified Water, Clean Utilities).
Sterile manufacturing or aseptic processing environments.
Must have Full Right to Work in the UK for duration of contract.
No Sponsorship provided.
What you'll get in return Long-term contract opportunity.
Outside IR35 engagement.
Competitive day rate.
Opportunity to work on high-profile qualification and validation projects within a GMP manufacturing environment.
Collaborative project team and exposure to significant new asset introduction activities.
What you need to do now If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
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StudySmarter Expert Advice🤫
We think this is how you could land CQV / Validation Engineer (Equipment Qualification) OutsideIR35 in Watford
✨Network like a Pro
In the pharmaceutical industry, getting your foot in the door can often come down to who you know. So, connect with professionals through platforms like LinkedIn or attend industry-specific conferences and trade shows. These are golden opportunities to meet decision-makers and to showcase your expertise.
✨Show Off Your Expertise
As a freelancer, you really want to establish yourself as a go-to expert in your niche. Consider setting up a blog or contributing to pharmaceutical forums where you can share insights about trends and innovations. This will help increase your visibility and build credibility in the industry.
✨Join Freelance Platforms
Don't underestimate the power of freelance platforms that focus on the pharmaceutical sector. Websites like Upwork or industry-specific job boards can help you find gigs that match your skill set. Remember to tailor your profile to highlight your relevant experiences and credentials.
✨Leverage Your Local Networks
Since the pharmaceutical industry often hinges on relationships, reaching out to local universities or research institutions can lead to lead generation. They might have collaborations or projects looking for freelance talent. Plus, don’t forget to connect with local pharma associations for gigs and networking opportunities!
We think you need these skills to ace CQV / Validation Engineer (Equipment Qualification) OutsideIR35 in Watford
Some tips for your application 🫡
Showcase Your Expertise:In the pharmaceutical industry, it's super important to highlight your specific expertise. Make sure your CV or portfolio reflects your relevant experience—think clinical research, regulatory affairs, or drug development. Don’t forget to include any certifications or training you've completed that are particularly relevant to the role.
Include Case Studies or Project Samples:As a freelancer, your portfolio is your calling card. Include detailed case studies or samples from previous projects that highlight your contributions and results in the pharmaceutical sector. This could be anything from successful clinical trials you've worked on to regulatory submissions—use this to demonstrate your impact.
Articulate Your Availability and Rates:Freelance roles mean flexibility, so clarify your availability upfront. Be transparent about your rates too—this helps set the stage for negotiations. You can mention your preferred working hours and project lengths to align with what Hays might be looking for.
Tailor Your Cover Letter:Your cover letter should connect the dots between your experience and the needs of Hays. Use it to explain why you're interested in this freelance role specifically and how your background in the pharmaceutical industry can help solve their unique challenges. Let your personality shine through while remaining focused on professional achievements!
How to prepare for a job interview at Hays
✨Show Off Your Expertise
Freelancing in the pharmaceutical industry means you'll want to highlight your specialised knowledge. Make sure to showcase your experience with regulatory processes or clinical trials, as these are crucial in this field. Share specific projects you've worked on to demonstrate your capability!
✨Know Your Tools and Tech
If you've worked with any industry-specific software, like LabArchives or Empower, get ready to discuss your experience with them. Being familiar with these tools will set you apart during the interview, as they’re often central to project success in pharmaceuticals. Don’t forget to mention how you’ve used data analysis in your previous roles – it’s key in this sector!
✨Bring Your Portfolio to Life
As a freelancer, your portfolio is your calling card. Prepare a compelling presentation that outlines your previous projects, focusing on results and methodologies. Highlight any case studies or publications to show your contributions to research or development – this can really grab the attention of Hays.
✨Prepare for Scenario-Based Questions
Expect some scenario-based questions that might challenge your problem-solving skills in real-world contexts. Be ready to discuss how you would handle tight deadlines, regulatory hurdles, or unexpected findings in your projects. This will allow you to demonstrate not just your knowledge, but your practical abilities too!
