Mes Specialist (Manufacturing Execution Systems) - Oral & Solid Dose (Osd)

Site Name: UK - Hertfordshire - Ware Posted Date: Nov 22 2024 The role of the MES Specialist is to manage and maintain the Ware site's Manufacturing Execution Systems (MES), which include the sites' electronic batch records, to support business continuity and delivery of the company's 'Digital and Smart Manufacturing' ambition.
This role is aligned to the site's Oral and Solid Dose (OSD) manufacturing lines.
Key Responsibilities (include): Manage and support the design, development, and qualification of Manufacturing Execution Systems (MES Recipes).
Act as technical subject matter expert (SME) on manufacturing processes within OSD for Business As Usual (BAU), projects and Smart Manufacturing initiatives.
Act as point of contact for user support and technical issues- Support GSK Tech on Root causing/ Troubleshooting, as well as supporting Tech on introduction of designs for new lines/ suites products.
Oversee daily operations of electronic batch management systems (including developing recipes for manufacturing cell therapy products).
Assist in creating batch records and documents for new product introductions (at Ware manufacturing site).
Work with manufacturing quality partners and internal quality teams to develop processes and systems that ensure compliant and successful technology transfers, operations, and lifecycle management of GMP manufacturing processes (meeting all product delivery schedules).
This extends to setting up and facilitating a change forum to work with GPS, Production, Technical, Quality, Site IT to identify and implement changes and continuous improvement.
Collaborate with Manufacturing leadership team to ensure alignment and prioritise goals to meet site and corporate objectives.
Provide technical expertise to support troubleshooting efforts for MES.
Facilitate timely decision-making and promote active communication and information flow.
Work collaboratively and transparently with Quality Assurance to ensure high-quality cGMP manufacturing excellence.
Work with Production, Quality and Tech representatives to plan, prioritise, manage and execute updates to electronic Batch Record (eBR) designs as a result of process changes i.e.
Audit/ CAPA actions/ User feedback and associated documentation (i.e.
Change Controls, User Acceptance Testing, Move activities and Performance Qualification (PQ).
Support deployment of annual upgrades to gain new features/ functionality.
Represent their respective area in Regulatory Inspections of systems, and to create/manage A1PE dashboards.
On-Standby Allowance: These positions are aligned to the working week (eg; 7.5 hours a day, Monday to Friday).
However, please note that there is a requirement for occasional flexibility over the weekend (via call-out rota).
A Standby Allowance is paid for this flexibility.
This will be clarified in more detail during the interview.
About You: This role is a great opportunity to be instrumental in developing and delivering the Ware Site's future factory ambitions.
You will be working at the cutting edge of digital transformation within GSK, in a high-profile role with senior leadership involvement.
As this role is multi-faceted and includes liaising with a wide variety of stakeholders (including on-site production and operations teams), you must be a highly self-motivated individual who has strong experience of working in complex manufacturing situations.
You will be resilient and calm under pressure, with strong people skills and a proven ability to influence people to achieve objectives and drive performance.
You will have a strong continuous improvement mindset and be hands-on in your approach.
About Ware Manufacturing Site: Medicines at Ware are presented as either Respiratory devices or in Oral Solid Dose form, and the site has circa 1,500 highly-motivated and capable people working at it.
The Ware site holds a unique position in our network as the only site responsible for launching the company's pipeline of new medicines in oral and solid dose forms, as well as operating a high-volume commercial production for respiratory devices.
APPLICATION CLOSING DATE - Friday 6th of December 2024 (COB).
Basic Qualifications: Relevant knowledge / experience (eg; role requires technical understanding, advanced problem solving and solution development skills) Relevant technical qualifications / experience (eg; Degree in Computer Science or IT) Manufacturing Experience (eg; understanding/experience of working digital solutions in a GxP environment) GSK offers a range of benefits to its employees, which include, but are not limited to: Competitive base Salary Annual bonus based on company performance Opportunities to partake in on the job training courses Opportunities to attend and partake in industry conferences Opportunities for support for professional development Access to healthcare and wellbeing programmes Employee recognition programmes If you would like to learn more about our company wide benefits and life at GSK we would suggest looking at our webpage Life at GSK | GSK .
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a special purpose - to unite science, technology and talent to get ahead of disease together - so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns - as an organisation where people can thrive.
We prevent and treat disease with vaccines, specialty and general medicines.
We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).
Our success absolutely depends on our people.
While getting ahead of disease together is about our ambition for patients and shareholders, it's also about making GSK a place where people can thrive.
We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be.
A place where they can be themselves - feeling welcome, valued, and included.
Where they can keep growing and look after their wellbeing.
So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.
As an Equal Opportunity Employer, we are open to all talent.
In the US, we also adhere to Affirmative Action principles.
This ensures that all qualified applicants will receive equal consideration for employment without regard to neurodiversity, race/ethnicity, colour, national origin, religion, gender, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class*(*US only).
We believe in an agile working culture for all our roles.
If flexibility is important to you, we encourage you to explore with our hiring team what the opportunities are.
Should you require any adjustments to our process to assist you in demonstrating your strengths and capabilities contact us on ****** or 0808 234 4391.
Please note should your enquiry not relate to adjustments, we will not be able to support you through these channels.
However, we have created a UK Recruitment FAQ guide.
Click the link and scroll to the Careers Section where you will find answers to multiple questions we receive .
As you apply, we will ask you to share some personal information which is entirely voluntary.
We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions.
We would really appreciate it if you could take a few moments to complete it.
Rest assured, Hiring Managers do not have access to this information and we will treat your information confidentially.
Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site.
All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK.
The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK.
In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK.
GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.
Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.
This capture of applicable transfers of value is necessary to ensure GSK's compliance to all federal and state US Transparency requirements.
For more information, please visit GSK's Transparency Reporting For the Record site.