At a Glance
- Tasks: Lead technical design and troubleshooting for critical utility systems in a biopharma environment.
- Company: Join Sanofi, an innovative biopharma company dedicated to improving lives through science.
- Benefits: Enjoy competitive pay, health benefits, and generous parental leave.
- Other info: Be part of a supportive team with endless career growth opportunities.
- Why this job: Make a real impact on healthcare by optimising clean utilities and driving innovation.
- Qualifications: Bachelor’s degree in engineering and 7+ years of relevant experience required.
The predicted salary is between 38250 - 46750 £ per year.
Location: Waterford, Ireland
Contract type: Fixed-Term, 23-months
About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.
About the job: The Senior Clean Utilities Specialist/SME is the site's technical authority for all critical utility systems supporting GMP manufacturing — including Purified Water (PW), Water for Injection (WFI), Clean Steam (CS), and cleanroom HVAC. This is a hands-on technical expert role responsible for system design integrity, troubleshooting complex technical issues, ensuring regulatory readiness, and driving continuous improvement and innovation across the site's clean utilities infrastructure.
Main responsibilities:
- System Design & Engineering: Lead technical design reviews for new installations, upgrades, and modifications to PW, WFI, CS, and HVAC systems. Develop User Requirement Specifications (URS) and technical specifications for capital projects. Ensure designs incorporate GMP principles.
- Troubleshooting & Root Cause Analysis: Serve as the site's escalation point for complex technical failures across all clean utility systems. Lead root cause investigations and develop robust CAPAs for unplanned utility disruptions, excursions, or EM/chemical/endotoxin deviations. Apply advanced troubleshooting techniques (trend analysis, failure mode analysis) to prevent recurrence.
- Regulatory Compliance & Audit Support: Act as key SME during regulatory inspections and internal/external audits for critical utility systems. Ensure ongoing compliance with Pharmacopoeial standards for water and steam quality. Support and review qualification documentation (IQ/OQ/PQ) and periodic requalification activities.
- Process Optimization & Continuous Improvement: Identify and implement reliability, maintainability, and efficiency improvement opportunities. Drive continuous improvement initiatives to reduce downtime, extend asset life, and improve system robustness. Partner with Reliability Engineering and Planning & Scheduling teams to optimize maintenance strategies.
- Technology Innovation & Digitalization: Evaluate and pilot emerging technologies for clean utilities applications. Champion digitalization of monitoring, alarming, and data trending for critical systems.
- Cross-Functional Technical Leadership: Provide technical mentorship and training to maintenance technicians and junior engineers. Represent clean utilities in cross-functional project teams (Quality, Validation, Production, EHS). Contribute site expertise to network/global technical forums and best-practice sharing.
- Vendor Management & Technology Assessment: Evaluate and select equipment vendors and service providers for clean utilities systems. Manage technical relationships with OEMs and service contractors; assess new technology solutions during capital planning.
About you:
Required Experience & Capabilities: Bachelor’s degree in engineering (Mechanical, Chemical, or related) or equivalent technical qualification. 7+ years of experience operating and troubleshooting GMP critical utility systems in pharmaceutical, biotech, or comparable high-purity manufacturing (semiconductor, food/beverage). Demonstrated experience leading root cause investigations and CAPA development. Experience supporting regulatory audits/inspections as a technical SME. Working knowledge of CMMS, qualification protocols (IQ/OQ/PQ), and change control processes. Familiarity with emerging digital/PAT technologies is a plus.
Technical skills: GMP Compliance, Energy Engineering, Utility Systems Design, Project management, Preventative and Corrective Maintenance, RCA and CAPA development.
Why choose us? Bring the miracles of science to life alongside a supportive, future-focused team. Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.
Clean Utilities SME Engineer in Belfast employer: Sanofi EU
Sanofi Waterford is an exceptional employer, offering a dynamic and supportive environment for MSAT Graduates to thrive. With a strong commitment to employee wellbeing, the company provides flexible working arrangements, access to an onsite gym and medical centre, and numerous opportunities for professional growth through structured training and mentorship. The collaborative work culture fosters innovation and teamwork, making it an ideal place for graduates to launch their careers in the biopharmaceutical industry.
StudySmarter Expert Advice🤫
We think this is how you could land Clean Utilities SME Engineer in Belfast
✨Get Hands-On with Temporary Projects
Temporary roles are all about flexibility and quick results. Look for short-term engineering projects or gigs that local companies might need help with. You can find these on job boards like Indeed or even niche platforms like PeoplePerHour. Don't be shy to reach out directly to firms—sometimes they have needs that aren't posted yet!
✨Tap into Engineering Meetups
Networking is key in engineering, especially for temporary positions. Check out local engineering meetups or hackathons relevant to your interests. Engaging with peers can lead to leads on temporary roles. Plus, it’s a sweet way to showcase your skills and passion in person—who knows who might be hiring at one of these events?
✨Leverage Your Connections
Let your friends and family know you're on the hunt for a temporary engineering role. Often, personal recommendations can get you in the door faster than any application. Share your goals and what you’re looking for through social media or casual conversations; you’d be surprised how many people might have the right connections!
✨Stay Sharp with Online Courses
While you're searching, keep those skills fresh! Take on some online courses related to your engineering field. Platforms like Coursera or edX can help you stay current and even get some certifications under your belt. This shows potential employers at Sanofi EU that you’re committed to growth, making you a more appealing candidate for temporary roles.
We think you need these skills to ace Clean Utilities SME Engineer in Belfast
Some tips for your application 🫡
Highlight Your Versatile Engineering Skills:For a temporary engineering role like this one at Sanofi EU, make sure to showcase a broad range of your engineering skills. Talk about different projects you’ve undertaken, focusing on your problem-solving ability and adaptability—key traits for temporary positions that depend on quick integration into teams.
Be Clear About Your Availability:Since this is a temporary role, clarity is essential. In your cover letter, be upfront about your availability and how soon you can start. Employers like Sanofi EU want to know that you can hit the ground running, so don’t shy away from mentioning your flexibility!
Tailor Your CV to Showcase Relevant Experience:Make sure your CV is tailored to reflect the specific engineering projects relevant to the job. For instance, if you’ve worked on temporary contracts before or have engaged in diverse engineering processes, highlight these experiences to show how well-rounded you are.
Include References from Past Employers:Temporary positions often require trust and reliability. Adding references from previous employers can significantly boost your application. It shows that you have a strong work ethic and can adapt quickly, which is exactly what Sanofi EU will be looking for.
How to prepare for a job interview at Sanofi EU
✨Get to Grips with Your Technical Skills
Engineering roles often involve assessing your technical expertise, so be prepared to delve into your core skills. Brush up on relevant software and tools you’ve used before, as well as any engineering principles that relate to the position at Sanofi EU. We want you to showcase your hands-on experience and problem-solving capabilities – it could be the difference between you and another candidate!
✨Prepare for Problem-Solving Scenarios
Expect to tackle some practical scenarios during the interview. Whether it's a design challenge or a troubleshooting test, Sanofi EU might want to see how you approach real-world engineering problems. Think of specific examples from your past work where you had to think on your feet and be ready to walk your interviewers through your thought process.
✨Show Your Adaptability in Temporary Roles
Since this is a temporary position, it’s key to demonstrate your flexibility and ability to hit the ground running. Make sure to convey your eagerness to learn and adapt quickly to the team and the specific projects at Sanofi EU. We all know that temporary roles can be a bit of a whirlwind, so emphasise your quick learning skills and your approach to managing change.
✨Highlight Relevant Portfolio Projects
If you've worked on engineering projects that align with the role at Sanofi EU, make sure to bring them up! A portfolio can be a great way to illustrate your engineering prowess. Discuss the challenges you faced, the solutions you implemented, and the results achieved – this will give the interviewers a tangible idea of what you bring to the table.
