Process Analytical Technology (PAT) Engineer

Job description

Details:

GSK are a science-led global healthcare company that researches and develops a broad range of innovative medicines and brands. Our products are used by millions of people around the world, helping them to do more, feel better and live longer. Employing close to 100,000 people globally, we have 87 manufacturing sites around the world.

Our pharmaceuticals business researches, develops and makes available medicines that treat a variety of serious and chronic diseases. We have medicines available or in development in a wide range of areas including:
• infectious diseases
• cancer
• epilepsy
• heart disease
• asthma and chronic obstructive pulmonary disease
• HIV/AIDS

Ware Manufacturing Site

Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form. The site holds a unique position in our network as the only site responsible for launching the company's pipeline of new medicines in these dose forms, many of which are life saving medicines. Every day an estimated 7 million patients use one of our respiratory devices or oral solid dose products. A series of investments in new state-of-the-art equipment are being made that will support the delivery of a record number of new products. This must be achieved whilst consistently delivering outstanding quality, service and value to our patients.

An excellent new opportunity is currently available for a Process Analytical Technology (PAT) Engineer to be based at GSK's flagship NPI site in Ware in Hertfordshire. The role will involve being part of a small team of PAT Engineers, Chemometricians and Process Engineers all working towards the same goal of ensuring that GSK products are manufactured to the highest standards for the patients at the end of the supply chain. We are looking for an individual with a highly specialised knowledge of PAT principles as well as CPP, CQA and MVDA (Multivariate Analysis).

Reporting to the Process Engineering Manager, the appointee will provide expertise to customers at all levels of the Ware GMS site, across both New Product Introduction (NPI) and Global Supply (GS) areas. Through the adoption of Process/Analytical best practices and principles, s/he will be expected to devise and implement novel solutions which meet business objectives and customer needs and fulfil service, quality, cost, safety and environmental standards. The role within the technical function focuses on delivery of process and product understanding supporting the Technical function's delivery of robust and reliable cost effective processes throughout product lifecycles. The selected candidate will have a fantastic opportunity for development in a fast paced and dynamic environment.

Key responsibilities include:

• To provide expertise to customers at all levels of the Ware GMS site in support of NPI or GS
• By applying Process/Measure Technology best practices and principles you will meet business objectives of service, quality, cost, safety and environmental standards. This will involve leading Processing elements across a number of key projects.
• To focus on delivery of Process Analytical principles, influencing and leading process capability improvement projects for both NPI and GS.
• To provide technical leadership in PAT applications that support the NCE development process within the supply chains working in conjunction with Pharmaceutical Development (PD) teams.
• The role is strongly aligned to;
- both of the site's supply chains – Respiratory (RSC) and Oral Solid Dose (tablets and powders) (OSD)
- the above-site technical groups, Centres of Excellence, Shared Services and Pharmaceutical Development (PD). This role will develop, maintain and enhance these relationships.
- production support for NPI and GS
• Provide support for troubleshooting (Root Cause Analysis) of manufacturing processes where known problems exist or support is required.
• Support production during NPI and Global Supply campaigns
• Support external and internal audits/inspections as required.
• Training and coaching of colleagues in principles and applications to wider matrix teams
• Work with Process Engineers and Chemometrics Experts to exploit the relationship between measurement, impact of variability of the whole process and equipment and their integration within the control strategy to ensure predictable and stable processes operations.

Closing date for applications: Friday 9th September 2016

When applying for this role, please use the 'cover letter' of the on-line application to clearly describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter will be used to assess your application.

Thank you for your interest in this opportunity.

Contact information:

You may apply for this position online by selecting the Apply now button.

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Desired profile

Basic qualifications:

• BSc (or equivalent) / PhD qualification with experience in analytical techniques.
• Experience in a manufacturing environment
• Experience in Spectroscopic Techniques, e.g. RAMAN NIR
• Experience of the Pharmaceutical industry (preferably Secondary) or related industries
• Experience in new and novel equipment design
• Awareness of the Pharmaceutical drug delivery/Technical Transfer process
• Project Management and Validation experience
• Must have good communication skills, working in a matrix organization with a variety of stakeholders.

Preferred qualifications:

• Project Management Skills and knowledge of equipment validation approaches
• Competent and reasoned approach to understanding new processes.
• Good Technical Report Writing skills
• Desirable to have experience of Spectroscopic method and model development and validation
• Desirable to have knowledge of regulatory requirements for PAT techniques
• Desirable to have Green Belt in OE, and ability to problem solve