Team Horizon is seeking a Senior Project Engineer for a leading pharmaceutical company in the Midlands. The ideal candidate will have experience in the delivery of equipment vendor packages through the key stages of the equipment lifecycle model (concept design, procurement, vendor management activities, onsite install and testing through to operational readiness support) within an aseptic manufacturing environment. The primary function of the role is to support from startup, the activities associated with the installation of a flexible combi aseptic fill line, for small scale commercial launch and product development batches.
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.
• You thrive on working with cutting edge technologies in a highly collaborative environment.
• You have knowledge of the key steps associated with the delivery of the equipment lifecycle model within an aseptic fill finish facility.
• You have lead or supported previous start-up projects and have experience working within a cross functional team set-up.
What you will be doing:
• Lead the end-to-end equipment lifecycle for key vendor packages associated with aseptic manufacturing projects.
• Provide strategic project leadership, ensuring equipment-related activities are delivered on time, within budget, and in compliance with cGMP and safety standards.
• Manage and prioritise multiple equipment-related projects, overseeing timelines, resources, cost, and external vendor communications.
• Collaborate with cross-functional stakeholders including Engineering, QA, Validation, Operations, Maintenance, and EHS departments to delivery the project.
• Support equipment selection, procurement, FAT/SAT execution, installation, commissioning, and qualification activities.
• Support the introduction of new processes, equipment, and materials, ensuring smooth transition to operational readiness.
• Support troubleshooting and issue resolution for equipment-related problems prior to qualification and start-up.
• Support the implementation of preventive maintenance programs and optimise spare parts strategy for new equipment to ensure lifecycle sustainability.
• Promote a strong safety culture, ensuring compliance with all relevant EHS policies and procedures.
What you need to apply:
• Bachelor’s degree in engineering (Mechanical, Electrical or Chemical) or Relevant Experience.
• Typically, 5+ years engineering experience, preferably in the biotechnology industry / aseptic pharmaceutical environment.
• In-depth knowledge of GMPs, FDA/EMA regulations, and industry standards for aseptic manufacturing.
• Proven project management experience.
• Experience in MS Office, MS Project, Change Control & Document Management Systems.
• Proven ability working cross functionally, delivering technical solutions and implementing improvements.
• Solid leadership skillset and experience working in a team environment, embracing an interdependent working culture that delivers results.
•Experience in managing vendor relationships, supporting testing activities at vendor and customer site execution, and working within a capital project framework.
• PMP certification or similar project management credential is advantageous.
