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- Tasks: Join us as a CQV Engineer, focusing on commissioning protocols and system testing.
- Company: Be part of a leading pharmaceutical company in South Dublin, dedicated to improving health outcomes.
- Benefits: Enjoy a 12-month contract with potential extension and a culture of continuous improvement.
- Other info: Collaborate with cross-functional teams and work on large-scale projects.
- Why this job: Make a real impact by ensuring high-quality medicines reach patients worldwide.
- Qualifications: Bachelor’s or Master’s in Engineering with 5 years of C&Q experience in Life Sciences required.
Team Horizon is seeking a CQV Engineer a leading pharmaceutical company in South Dublin.
Scroll down for a complete overview of what this job will require Are you the right candidate for this opportunity
We\’re looking for a versatile C&Q engineer to assist with early deliverables and ensure efficient processes. This role will initially engage with support from the projects team, transitioning to a more onsite position. The contract is for 12 months with the potential for extension, focusing on enabling works, document creation, and vendor pack reviews, while collaborating with engineering, ETL, quality system owners, and a cross-functional team. Candidates should have diverse exposure, possibly across drug substance, drug product, utilities, or process equipment, highlighting adaptability in large-scale projects.
Why you should apply:
* This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
* There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
* Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
* Develop and execute commissioning protocols (FAT, SAT, IV, FT) for GMP-regulated systems.
* Perform system startup, debugging, and initial testing of facility, process, and utility systems.
* Ensure systems are installed and operating per design specifications.
* Collaborate with cross-functional teams (Engineering, Manufacturing, Quality) during equipment installation and commissioning.
* Review and verify technical documentation (P&IDs, wiring diagrams, datasheets).
* Conduct risk assessments and develop test plans for facility and utility systems.
* Ensure compliance with GAMP, ISPE guidelines, and regulatory requirements (FDA, EMA).
* Redline engineering drawings and participate in system walkdowns.
* Prepare and execute C&Q documentation and summary reports.
* Support continuous improvement initiatives related to C&Q processes.
* Any other duties as assigned.
What you need to apply:
* Bachelor’s or Master’s degree in Engineering (Mechanical, Chemical, Biopharmaceutical, or related field).
* Minimum 5 years of experience in C&Q within the Life Sciences industry.
* Strong knowledge of regulatory guidelines (FDA, EMA, ISPE, GAMP).
* Hands-on experience with risk-based qualification and C&Q protocols.
* Experience with HVAC systems, black/clean utilities, filling lines, component prep, and temperature-controlled equipment.
* Proficient in reviewing/redlining engineering documents.
* Familiarity with Data Integrity and Computer System Validation (CSV).
* Experience with digital execution tools (e.g., Kneat, EDMS).
* Strong problem-solving, communication, and teamwork skills. Experience working on large-scale capital projects is a plus
CQV Engineer employer: Team Horizon
Contact Detail:
Team Horizon Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land CQV Engineer
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those who have experience in CQV roles. Attend industry conferences or local meetups to connect with potential colleagues and learn about job openings that may not be advertised.
✨Tip Number 2
Familiarise yourself with the latest regulatory guidelines and standards relevant to CQV engineering, such as GAMP and ISPE. This knowledge will not only boost your confidence during interviews but also demonstrate your commitment to staying updated in the field.
✨Tip Number 3
Consider reaching out to current or former employees of the company to gain insights into their work culture and expectations for the CQV Engineer role. This can help you tailor your approach and show genuine interest during the application process.
✨Tip Number 4
Prepare to discuss specific examples from your past experiences that highlight your problem-solving skills and adaptability in large-scale projects. Being able to articulate these experiences clearly can set you apart from other candidates.
We think you need these skills to ace CQV Engineer
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in C&Q engineering, particularly within the Life Sciences industry. Emphasise your hands-on experience with risk-based qualification and any specific projects that align with the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your understanding of the role. Mention your adaptability and experience with large-scale projects, as well as your familiarity with regulatory guidelines like FDA and EMA.
Highlight Relevant Skills: In your application, clearly outline your skills related to commissioning protocols, technical documentation review, and collaboration with cross-functional teams. Use specific examples to demonstrate your problem-solving abilities and teamwork skills.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors or inconsistencies. A polished application reflects your attention to detail, which is crucial in the C&Q engineering field.
How to prepare for a job interview at Team Horizon
✨Know Your Regulatory Guidelines
Familiarise yourself with the key regulatory guidelines such as FDA, EMA, ISPE, and GAMP. Be prepared to discuss how your experience aligns with these standards and how you have applied them in previous roles.
✨Showcase Your Technical Skills
Highlight your hands-on experience with C&Q protocols and risk-based qualification. Be ready to provide specific examples of projects where you developed and executed commissioning protocols, demonstrating your technical expertise.
✨Emphasise Team Collaboration
This role requires working closely with cross-functional teams. Share examples of how you've successfully collaborated with engineering, manufacturing, and quality teams in past projects, showcasing your teamwork and communication skills.
✨Prepare for Problem-Solving Scenarios
Expect questions that assess your problem-solving abilities. Prepare to discuss challenges you've faced in large-scale projects and how you approached them, particularly in relation to system startup and debugging.