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Job description

Project Engineer (Chemical Engineer) (Job Ref: 25N/PREN) Randox Laboratories continues to develop disruptive innovations within the Diagnostics and Healthcare sector globally. We are proud to have been named the Number 1 company in Northern Ireland, for the second consecutive year in the Belfast Telegraph Top 100 Companies 2024. Our staff are at the heart of everything we do and achieve. We have an exciting career opportunity for a Project Engineer join our dynamic team within the IVD Industry predominantly in Serum QC, R&D and Manufacturing Support. Location: Randox Science Park, 30 Randalstown Rd, Antrim BT41 4FL. Contract Offered: Full-time, Permanent. Working Hours / Shifts: 40 hours over four days per week: Monday to Thursday, 8am to 6.40pm. What does the Project Engineer role involve? The successful candidate will lead and contribute to cutting edge R&D projects, from concept development through to product launch as well as supporting existing manufacturing challenges and continual process improvement. The successful candidate will work at the intersection of engineering, science and healthcare, driving innovation in diagnostic manufacturing processes that make a real difference to healthcare worldwide. Some of the key duties of the role will include:

Responsibilities

• Lead R&D projects from a technical engineering perspective.
• Design, develop and optimize new and existing quality control products.
• Using chemical engineering expertise, investigate and root cause current manufacturing challenges and issues to continually improve quality and profitability.
• Develop new cutting-edge manufacturing processes for current processes.
• Develop and scale-up manufacturing processes for various IVD products.
• Identify emerging technologies and maintain a competitive edge to other serum QC manufacturers.
• Ensure all projects comply with UK, EU and global regulatory requirements, including ISO13485 and IVDR standards.
• Analyse experimental and production data to guide design improvements and ensure product performance.
• Prepare technical reports, protocols and all other associated documentation as per Randox procedures.
• The troubleshooting of formulation queries and continual improvement of formulation processes including continual improvement of departmental ISO procedures.
• The risk management, verification and validation of the serum quality control manufacturing process and any changes made.
• Attendance at regular manufacturing meetings.

Skills and Qualifications

Essential Skills

• Bachelors degree in chemical engineering or a related discipline.
• 3 years experience in a relevant industry.
• Willingness to be practical and hands-on as well as perform theoretical research.
• Proven experience within the IVD, medical device or biotechnology industries.
• Strong understanding of chemical engineering principles, including fluid dynamics, mass transfer and reaction engineering.
• Knowledge of ISO 13485, IVDR and other relevant standards and regulations.
• Proficient in project management methodologies and tools.
• Excellent problem-solving and analytical skills.
• Computer literate with experience in the use and application of Microsoft packages.
• Strong written and verbal communication skills and able to convey complex ideas effectively to a wide audience.

Desirable Skills

• Masters or PhD in chemical engineering.
• Qualified Chartered Engineer with the IChemE.
• Experience with Design of Experiments and Statistical Analysis Techniques.
• Experience with Lyophilisation including associated manufacturing process development technologies.
• Experience with CIP (Clean-in-place), as well as vial filling, capping and labelling.
• Knowledge of automated processes and equipment, pumps, valves, PLC control.