- Lead PAT system implementation and deployment across GSK Global Supply Chain Locations
- Manage Enterprise PAT system in a validated state, following standard operating procedures (SOPs) for working in a validated environment
- Create system documentation per IT Management System (ITMS) SOPs such as user requirement specifications, system requirements, system overview, design specification, configuration specification, system specification, etc.
- Provides technical leadership to ensure the PAT applications are aligned with business needs
- Develop a standardized Technical Installation Plan (TIP) for new platform installations and manage the execution of the installation as well as recording any deviations or defects in the Technical Installation Record (TIR)
- Support delivery and validation of new installations using a standardized risk based Testing Plan to verify platform meets all system requirements before the release
- Manage system security and access controls to maintain data integrity and compliance
- Monitor PAT system performance, troubleshoot issues, and identify opportunities to continuously improve the system reliability
- Provide technical support and guidance for system users, address system related inquiries and resolve technical issues
- Plan and perform system modifications and upgrades following SOPs for validated systems
- Support the lifecycle management of PAT (equipment, model & data infrastructure requirements) across sites
- BS in either computer science, engineering, automation or a related degree
- 5+ years experience with manufacturing systems
- Advanced knowledge of systems integration deploying complex systems integration solutions, including integration of PAT tools (e.g. spectroscopic analyzers, sensors, automated and statistical data analysis) and process control systems (e.g. SCADA, DCS, and PLCs) using OPC UA protocols
- Experience with software development lifecycle and working with software vendors to adopt changes to their products
- Outstanding writing and documentation skills (in English)
- Experience working in a team-oriented, collaborative environment
- Experience with Advanced Process Technology solutions in GxP environment
- Knowledge of relational database design and management techniques, especially with Microsoft SQL Server.
- Knowledge and practical experience in computer and application validation (preferably using GAMP methodology), cGMPs, and 21 CFR Part 11 in an FDA-regulated environment
- Experience with business and technical requirements analysis, business process modelling/mapping and methodology development, and data mappinHighly self-motivated and directed, with keen attention to detail.
- Experience integrating PAT solutions with process historian and visualization software such as OSI PI or Aspen IP21
- Good knowledge of IT architecture management & implementation processes
- Have an understanding of Pharmaceutical Manufacturing Processes
- Strong knowledge of ALCOA+, GxP validation requirements, and quality assurance/data integrity for computer systems
- Strong conceptual thinking, modelling, analytical and problem-solving skills, strong interpersonal and communication skills
- Ability to communicate ideas in both technical and user-friendly language
Benefits:
• Career at one of the leading global healthcare companies
• Attractive reward package (competitive salary, annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit
• Possibilities of development within the role and company's structure
• Life insurance and pension plan
• Open and inclusive environment which is supportive and welcoming of all diversity strands (gender, race, ethnicity, sexuality, disability, or any other characteristic)
• Private medical package with additional preventive healthcare services for employees and their eligible counterparts
• Sports cards (Multisport)
• Personalized learning approach and external trainings
• Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities)
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits everyday
• Free car and bike parking, locker rooms and showers #LI-GSK G7 -
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PAT System Senior Engineer - Poznań, Polska - 9605 GSK Services Sp z o.o.
Opis
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. Getting ahead means preventing disease as well as treating it, and we aim to impact the health of 2.5 billion people around the world in the next 10 years.
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 a PAT System Engineer, you will be a leading technical contributor who can consistently take a loosely defined business or technical requirement, architect and build it to a well-defined specification, and execute on it at a high level. By collaborating with the Product Manager, Business Partners, MSAT and Automation team to design, develop and implement digital and technology solutions, a PAT System Engineer ensures the PAT solutions are fit for purpose & use, cost-effective and/or innovative & in alignment with the Tech strategy.
Basic Qualifications
Preferred Qualifications:
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.
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.
