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Sterile Process Technologist Expert

3 mesi fa

Parma, Italia Gsk A tempo pieno

Site Name: Italy - Parma
Posted Date: Jul 25 2024
We create a place where people can grow, be their best, be safe, and feel welcome, valued, and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.
We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.
Discover more about our company wide benefits and life at GSK on our webpage Life at GSK | GSK The Sterile Process Technologist Expert provides technical expertise for a wide range of products, processes and activities for both existing and NPI projects across the Parma site (Biopharm products and small molecules) and provides first touch troubleshooting, working on technical projects (as required) and supply of technical data. 
In this role YOU will… Act as point of contact  for root cause analysis of material/product/processing/cleaning issues and rapid resolution.  Where required using multiple sources of data and data interpretation methods.  Take part in Continuous Improvement (CI) activities to highlight improvements to equipment and processes.
Act as a point of contact for the top3 waste and top3 quality and for the technical issues collection and evaluation
Act both independently and in a cross-functional teams to manage projects. Ensuring delivery of the operational technical responsibilities and project timelines.
Plan and conduct/supervise manufacture of batches with minimal supervision.  This is to ensure the project timescales are met and issues dealt with in real-time.
Perform technical coaching of operators to ensure knowledge transfer to the 'manufacturing shop floor' allowing operators to improve their accountability and timeliness of issue resolution.
Actively participate in projects to Support technology transfer of biopharm products :
Ensure that all project team members and the Project Leader are kept fully informed of progress and any technical issues. Ensure that input is based on the best/up to date information/ available on site and within the Company. Ensure that the Project Leader is advised of any resource issues such that the project is properly resourced and effectively executed. Ensure that the Project Leader is kept advised of any changes impacting on execution such that they can monitor and update progress against the project plan. Why YOU? Basic Requirements & Skills: Degree in Chemical engineering, Mechanical engineering, Medicinal chemistry or equivalent
Knowledge in Aseptic technique and sterilisation processes and the implications on product or material. 
Knowledge in filter validation (bacterial retention study, filter recovery, bubble point, forward flow, Viability ….)
Knowledge in single use system validation ( design/risk assessment/ IQ/OQ/extractable/ leachables….)
Knowledge in Biopharm product and lyophilization process step.
Fluency in English (written and spoken)
Preferred Requirements & Skills: Knowledge in Technology Transfer
Knowledge in 3 stage approach validation and regulatory submission
Knowledge of the structured problem-solving approaches used for all product & process issues.
#LI-Hybrid Closing Date for Applications – August 4th, 2024 Please take a copy of the Job Description, as this will not be available post closure of the advert. 
When applying for this role, please use the 'cover letter' of the online application or your CV to 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 and CV will be used to assess your application.
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.
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GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, 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.
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