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Maintenance Engineer
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.
Continued growth and investment into the business has led to the creation of exciting new job opportunities; in our new GMP Manufacturing headquarters in Beeston, Nottingham. Upperton Pharma Solutions is undergoing a period of significant expansion to meet international customer demand and offer a comprehensive drug development portfolio, so now is a great time to join our team.
Our values ensure that will be joining a team with a truly positive and progressive culture surrounded by state-of-the-art facilities where you as a leader can share your ideas with other gifted and dedicated scientists and clients from around the world all focused on developing new medicines.
The Role
Reporting to the Facilities Manager you will be responsible for all maintenance activities at the two Upperton sites, including facility and equipment assets.
This will include the development, implement and continuance of maintenance strategies and internal calibration processes.
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.
Essential Skills and experience:
Experience working within a Maintenance or Equipment Engineering role.
HNC/HND qualified.
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
Electrical Installation Qualified
Demonstratable experience of commissioning and qualifying process equipment
Experience of working within a GMP regulated environment.
Extensive experience working within the pharmaceutical industry, ideally within a CDMO or CMO.
Demonstratable understanding of the requirements within Eudralex Volume 4 Annex 15.
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 (CAPAs)
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 fund raising events.
