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- Tasks: Join us as a Validation Engineer to develop and execute validation protocols for cutting-edge biopharmaceutical equipment.
- Company: We are a leader in biopharmaceutical manufacturing, focusing on innovative single-use technology.
- Benefits: Enjoy a collaborative work environment with opportunities for professional growth and development.
- Why this job: Make a real impact in the biopharmaceutical industry while working with advanced technologies and cross-functional teams.
- Qualifications: You need a degree in Engineering or Biotechnology and 5+ years of relevant validation experience.
- Other info: Stay ahead of industry trends and contribute to regulatory compliance in a dynamic field.
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 any networking opportunities. Engaging with professionals in the biopharmaceutical industry can help you gain insights and potentially get referrals.
✨Tip Number 2
Stay updated on the latest trends and regulatory changes in single-use technology. This knowledge will not only help you in interviews but also demonstrate your commitment to the field and your proactive approach to professional development.
✨Tip Number 3
Consider joining relevant professional organizations or online forums where validation engineers discuss challenges and solutions. This can provide you with valuable connections and insights that may give you an edge in the application process.
✨Tip Number 4
Prepare to discuss specific examples of how you've conducted risk assessments and gap analyses in your previous roles. Being able to articulate your problem-solving skills and experiences will make you stand out as a candidate.
We think you need these skills to ace Validation Engineer
Some tips for your application 🫡
Understand the Role: Make sure to thoroughly read the job description for the Validation Engineer position. Understand the key responsibilities and qualifications required, especially focusing on single-use technology and validation protocols.
Tailor Your CV: Customize your CV to highlight relevant experience in validation within the biopharmaceutical industry. Emphasize your hands-on experience with single-use bioreactors and mixing systems, as well as your knowledge of GMP and FDA regulations.
Craft a Strong Cover Letter: Write a compelling cover letter that showcases your passion for the role and the industry. Mention specific examples of your past work related to validation protocols (IQ/OQ/PQ) and how you have ensured compliance with industry standards.
Highlight Collaboration Skills: In your application, emphasize your ability to collaborate with cross-functional teams. Provide examples of how you have worked with Manufacturing, Quality Assurance, and Regulatory Affairs to support validation efforts.
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 perform risk assessments effectively.
✨Collaborate Effectively
Since this role involves working with cross-functional teams, be ready to discuss your experience collaborating with Manufacturing, Quality Assurance, and Regulatory Affairs. Provide examples of successful teamwork and communication strategies you've employed.
✨Stay Updated on Industry Trends
Show your passion for the field by discussing recent advancements in single-use technology and regulatory changes. This demonstrates your commitment to continuous learning and staying informed about industry best practices.
