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- Tasks: Develop and execute validation protocols for biopharmaceutical equipment.
- Company: Join a leading company in biopharmaceutical manufacturing focused on innovation.
- Benefits: Enjoy competitive pay, professional growth opportunities, and a collaborative work environment.
- Why this job: Make a real impact in bioprocessing while working with cutting-edge technology.
- Qualifications: Bachelor’s or Master’s in Engineering or related field with 5+ years of validation experience.
- Other info: Hands-on experience with single-use technology is a must!
The predicted salary is between 36000 - 60000 £ per year.
We are seeking a skilled Validation Engineer with expertise in single-use technology (SUT) to support validation activities related to bioreactors, mixing systems, and other disposable process equipment used in biopharmaceutical manufacturing. The successful candidate will be responsible for the development and execution of validation protocols (IQ/OQ/PQ), ensuring compliance with GMP, FDA, EMA, and industry standards. This role is critical in ensuring the reliability, efficiency, and regulatory compliance of bioprocessing equipment.
Key responsibilities:
- Develop, execute, and document validation protocols (IQ, OQ, PQ) for single-use bioreactors, mixing systems, and other process equipment.
- Ensure compliance with GMP, FDA, EMA, ISO, and industry standards related to single-use technology.
- Perform risk assessments and gap analyses for single-use components to ensure process integrity.
- Collaborate with cross-functional teams, including Manufacturing, Quality Assurance, Process Development, and Regulatory Affairs, to support validation efforts.
- Investigate and resolve validation deviations, anomalies, and non-conformances.
- Author and review Standard Operating Procedures (SOPs), User Requirement Specifications (URS), and Validation Master Plans (VMPs).
- Lead and participate in FAT, SAT, and commissioning of single-use systems.
- Conduct performance qualification studies, including sterility, extractables & leachables testing, and integrity testing.
- Stay updated with industry trends, technological advancements, and regulatory changes affecting single-use technologies.
- Provide training and technical support on validation processes to internal stakeholders.
Qualifications:
- Bachelor’s or Master’s degree in Engineering, Biotechnology, Biochemistry, or a related field.
- 5+ years of validation experience in the biopharmaceutical or medical device industry.
- Hands-on experience with single-use bioreactors, mixing systems, and filtration assemblies.
- Strong knowledge of GMP, FDA 21 CFR Part 11, ISO 13485, USP, and ICH guidelines.
- Experience with risk-based validation approaches and industry best practices.
- Familiarity with data integrity principles, electronic validation systems, and automation is a plus.
Please get in touch if you are interested in applying!
Validation Engineer employer: Hamlyn Williams
Contact Detail:
Hamlyn Williams Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Validation Engineer
✨Tip Number 1
Make sure to highlight your hands-on experience with single-use bioreactors and mixing systems during the interview. Be prepared to discuss specific projects where you developed or executed validation protocols, as this will demonstrate your practical knowledge.
✨Tip Number 2
Familiarize yourself with the latest trends and regulatory changes in single-use technology. Showing that you are up-to-date with industry advancements can set you apart from other candidates and show your commitment to continuous learning.
✨Tip Number 3
Prepare to discuss your experience with cross-functional collaboration. Since this role involves working with teams from Manufacturing, Quality Assurance, and Regulatory Affairs, having examples ready of how you've successfully collaborated in the past will be beneficial.
✨Tip Number 4
Be ready to explain your approach to risk assessments and gap analyses. Providing concrete examples of how you've identified and mitigated risks in previous validation projects will showcase your analytical skills and attention to detail.
We think you need these skills to ace Validation Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your relevant experience in validation engineering, particularly with single-use technology. Emphasize your hands-on experience with bioreactors and mixing systems, as well as your knowledge of GMP and FDA regulations.
Craft a Strong Cover Letter: In your cover letter, express your passion for biopharmaceutical manufacturing and detail how your skills align with the responsibilities listed in the job description. Mention specific projects or experiences that demonstrate your expertise in validation protocols (IQ/OQ/PQ).
Showcase Your Technical Skills: Highlight your technical skills related to risk assessments, gap analyses, and compliance with industry standards. Provide examples of how you've successfully collaborated with cross-functional teams to support validation efforts.
Proofread and Format: Before submitting your application, carefully proofread all documents for spelling and grammatical errors. Ensure that your formatting is consistent and professional, making it easy for the hiring team to read your application.
How to prepare for a job interview at Hamlyn Williams
✨Showcase Your Technical Expertise
Be prepared to discuss your hands-on experience with single-use bioreactors and mixing systems. Highlight specific projects where you developed or executed validation protocols, emphasizing your understanding of GMP, FDA, and ISO standards.
✨Demonstrate Problem-Solving Skills
Expect questions about how you've handled validation deviations or non-conformances in the past. Share examples that illustrate your analytical thinking and ability to collaborate with cross-functional teams to resolve issues.
✨Stay Updated on Industry Trends
Research the latest advancements in single-use technology and regulatory changes. Being knowledgeable about current trends will show your commitment to the field and your proactive approach to continuous learning.
✨Prepare for Behavioral Questions
Think of scenarios that demonstrate your teamwork and communication skills, especially in collaborative environments. Be ready to explain how you’ve contributed to team success in validation efforts and training internal stakeholders.
