Pharmaceutical Manufacturing Process Specialist Jobs in Swindon – England – UK at Thermo Fisher Scientific
Title: Pharmaceutical Manufacturing Process Specialist
Company: Thermo Fisher Scientific
Location: Swindon – England – UK
Type: Full Time
Category: Management, Engineering
Position: Pharmaceutical Manufacturing Process Specialist – Swindon
When you’re part of Thermo Fisher Scientific, you’ll do challenging work, and be part of a team that values performance, quality and innovation. As part of a successful, growing global organization you will be encouraged to perform at your best. With revenues of more than $20 billion and the largest investment in R&D in the industry, we give our people the resources and opportunities to make significant contributions to the world.
in Swindon, ThermoFisher are forging partnerships that are transforming the industry, creating new business models between pharma companies and their pharma service providers. We are pioneering solutions that are driven by client needs, with successful recent partnerships including Amgen, Flexion, Pacira and Grünenthal.
We currently offer solutions spanning the entire pharmaceutical life cycle to help pharma and biotech companies of all sizes meet their complex development and manufacturing needs at any stage or scale enabling us to deliver a combination of unrivaled quality, reliability and compliance, backed by a reputation for scientific and technical excellence.
The range of services at ThermoFisher for drug substances and drug products is wider than that of any other CDMO and we offer end-to-end capabilities and expertise to take your discovery from pre-clinical and clinical development, through scale-up, all the way to commercial supply across more than 40 oral solid, sterile and softgel dosage forms.
About the position:
Our Process Specialist will be support our Condo Operations Lead in delivering equipment and process establishment and qualification activities. In addition you’ll generate process documentation and approvals using our QMS tools. You’ll also focus on training and up-skilling staff with the manufacturing condo.
In addition, the role will involve:
Technical transfer of process changes to cGMP Operations.
SME function for aseptic processes ranging from bulks to fill finish and visual inspection.
Supporting the implementation and delivery of effective, safe and compliant production manufacturing operations within the agreed organisation framework.
Ensuring the process for products to be manufactured is set up and maintained in accordance with cGMP, Standard Operating Procedures and other regulatory agency requirements.
Actively working with and supporting other members of the team in delivering commercial demand and project support.
Being integral in championing and establishing robust lean compliant processes as all stages of the process, leading VSM and refining working standards.
Liaising with clients and suppliers as appropriate.
Working as an effective member of the team, liaising with other SMEs as appropriate to draw in expertise for delivering solutions.
Troubleshooting manufacturing, filling, inspection packaging processes to improve efficiency, yield and delivery.
Department lead for investigations and root cause analysis working alongside a multifunctional team. Trend quality incidents with implementation of robust improvements, measurable year on year.
Delivering technical reports and other associated quality reports as agreed with the department head.
Taking lead SME role for internal and external audits covering the aseptic processing end to end.
Science or Engineering based degree. Ideal…