R&D Sterile Manufacturing Process Engineer
4 settimane fa
Site Name: Italy - Parma
Posted Date: Oct 23 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 R&D Clinical Supply Chain Sterile Operations Parma department is looking for a Process Engineer to support clinical manufacturing business growth at Global Supply Chain Parma.
The new team member will work on projects in cooperation with GSC Parma and the R&D Project teams.
In this role, you will… Implement technical solutions at Pilot Plant to enable manufacturing of new drug products, with specific focus to new equipment and single-use system (SUS) qualification.
Define in conjunction with R&D project teams of the user requirements of the equipment/SUS
Define equipment design and technical specifications.
Addend, with Parma Procurement, to commercial tender with suppliers and cooperate with suppliers to elaborate technical solution and design of the equipment.
Be responsible of FAT/SAT of the equipment and execute documentation and on field activities to qualify the equipment/SUS
Elaborate plans and keep on track activities to deliver the equipment/SUS according to R&D project timelines.
Support Manufacturing Operation with training on equipment/SUS and SOPs.
The role, thanks to a variety of tasks, ensures knowledge acquisition on multiple R&D functions (Product Development, QA, Supply Chain) and interactions with several GSC Parma departments (Manufacturing Operations, QA, Regulatory, Validation, Micro and Chemical Labs).
Basic Qualifications & Skills :
Master's degree in Chemical or Mechanical Engineering.
Good written and spoken knowledge of Italian and English.
Good attitudes to team working and interactions with vendors / international stakeholders.
Experience in validation of pharmaceutical manufacturing process equipment
Experience in change control management process
Basic knowledge of aseptically filled drug products manufacturing process and related GMPs.
Preferred Qualifications & Skills: Experience in technical functions (e.g. engineering, technical area, validation).
Knowledge of terminally sterilized drug products manufacturing process; single-use system technology and freeze-drying process and equipment.
Project management experience.
Problem-solving tools knowledge.
Exposure to international and multi-functional environments.
Excel advanced user
What We Offer: Permanent contract in a very Inclusive environment
Smart Working
Flexible Benefits
Company Healthcare Plan
Integrative pension fund
Employee Assistance Programme
Sustainable mobility programme
Company canteen
Performance Reward
Closing Date for Applications – November 6th, 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.
If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at ******** (US Toll Free) or +******** (outside US).
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.
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.
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