Overview
Upperton Pharma Solutions is a Nottingham-based CDMO that specialises in the development and manufacture of pharmaceutical products, providing a complete service from early-stage feasibility to GMP clinical manufacture. Formulations cover a range of delivery routes, typically including oral (tablets & capsules), nasal and inhaled.
Role Title: Equipment Engineer
Reporting to: Engineering and Validation Manager
Hours of Work: 37.5 hours per week Monday to Friday. Core hours are 8am to 4pm. However, you may be required to work flexible around these core hours as necessary in order to meet the demands of the business.
The Role
The role of Equipment Engineer is responsible for actioning and overseeing the maintenance, calibration, and qualification of GMP Equipment. This will include the development of maintenance strategies, internal calibration processes and test methods. The Equipment Engineer will author and complete the required documentation, Technical Instruction and Protocols necessary to complete the above works in compliance with GMP. The post holder will ensure the above operations and activities are conducted within the framework of the Upperton Pharma Solutions Quality Management System and that all work meets regulatory requirements.
Main duties and responsibilities:
- Establish and maintain strong relationships with cross functional departments including Manufacturing, Quality Control, Quality Assurance and R&D.
- Champion Health & Safety, ensuring site maintenance activities are performed in a safe manner and that both equipment and the facility is maintained appropriately with safety and compliance at the forefront.
- Perform both Preventative and Reactive Maintenance on GMP Equipment
- Assist in the writing and execution of qualification/validation protocols.
- Author internal calibration processes and procedures for GMP Equipment.
- Author Technical Instructions and Maintenance/Service procedures for GMP Equipment.
- Ensure the management and upkeep of Equipment Databases.
- Manage Engineering & Validation Departmental Contractors in accordance with company procedures and processes.
- Build and maintain an inventory of critical spares for critical process equipment.
- Perform internal calibrations on GMP Equipment.
- Assist with Engineering Supplier and Contractor Management
- Support DQ/FAT/SAT/IQ/OQ/PQ activities for new GMP Equipment and Systems.
- Support the ongoing periodic Requalification and review of GMP Equipment and Systems.
- Work closely with the Manufacturing and Project Scheduling to ensure that equipment maintenance activities deliver minimum disruption to manufacturing output.
- Act as a Subject Matter Expert for Engineering related activities in the Engineering & Validation Managers absence.
Essential Skills and experience:
- Extensive experience working within the Pharmaceutical industry, ideally within a CDMO or CMO.
- Experience working within an Equipment Engineering role.
- HNC/HND qualified.
- Demonstratable experience of commissioning and qualifying process equipment is essential.
- Experience of working within a GMP regulated environment.
- Demonstratable understanding of the requirements within Eudralex Volume 4 Annex 15.
- Ability to work effectively and contribute within a team environment, as well as work proactively using personal initiative.
- Demonstratable planning and organisational skills.
- Ability to work accurately under pressure.
- Good working knowledge of Microsoft Office (Word, Excel, Access and Sharepoint).
Preferred experience
- An understanding of Computer System Validation (21 CFR Part 11, Eudralex Annex 11 and GAMP 5)
- Experience with writing, actioning and resolving, change controls, deviations and Corrective And Preventative Actions (CAPA’s)
What you will get in return
We offer employees not only a competitive salary but also an excellent suite of benefits including:
- 25 days plus bank holidays and your birthday off!
- Annual bonus based on company and individual performance
- Company contributory pension package
- Life insurance
- Private Medical Insurance through Vitality
- Internal and external training courses and professional development support
- Free onsite car parking
We know it is the little things that make every day special, so we also organise employee events for you to attend throughout the year, like our annual Christmas party, summer party and charity fundraising events.
Apply below with your CV and covering letter.
Closing date for applications is 18th April 2024.
