Process Engineer Specialist Primary
- Engineering degree or Master Engineering (Mechanical/ Civil / Chemical / Biotech or large expertise in these domains) : Strong technical background in Engineering – Process Equipment
- 4 – 6 years' experience in the required domain
- Broad knowledge of Technologies Primary processes.
- Deep and specific technical knowledge of Process Based Vaccines production (Viral and Bacterial)
- Deep Expertise in Homogenization Process (HPH, Grinder, other technologies) is a "Plus"
- Expertise in cGMP and good knowledge of Material Sciences (Stainless steel, welding,…)
- Expertise in Validation Methodology, Primary Equipment and Bio-safety.
- Knowledge of GSK Vaccines organization (QA-QC-Manufacturing-Regulatory-Validation) is a "Plus"
- Good networking inside and outside GSK Vaccines in his discipline is a "Plus"
Other Job-Related Skills/Background :
- Highly effective at influencing internally and externally
- Highly effective communication skills both verbal and written
- Has the ability to work fully autonomous
- Sense of urgency, flexibility and accountability.
- Ability to discuss and negotiate technical matters with suppliers
- Ability to communicate at all levels.
- Ability to work in a high complex matrix environment
- Fluent in English and French (written and spoken)
Provide support and expertize to a core group of technical engineers GSK or Contingents in the development of deep scientific & engineering understanding of manufacturing Operations and in the implementation of good engineering & design practices and solutions to support manufacturing, quality and research operations.
Act as the Process Engineer Specialist in GSK Vaccines Primary Equipment projects in Belgium (existing facility upgrades and new facilities – excluded strategic project) by delivering equipment in the following technologies
- Bioreactors (Cell Culture and Fermentation) and ancillary equipment (portable tanks, disposables bags, perfusions pumps, connecting, …)
- Inactivation Vessels or Skid
- Media, Buffer preparation Vessels and Process Vessels
- Purification Equipment (centrifuges, chromatography, micro-fluidizers, Ultra-Filtration, ….)
- Sterile final filtration
- CIP/SIP substation (cleaning and sterilization in place) link to Primary Equipment.
Challenge and support project and asset care teams on complex and Belgian transversal issues.
Proactively ensure and safeguard the quality and capabilities of the manufacturing, quality and research facilities within GSK Vaccines through the implementation of robust process and process support equipment design, installation, and technical guidelines
Support all Belgium GSK Vaccines sites concerning technical troubleshooting, and hands on training based on industry best practices
Act as fronter or support during internal and external inspection
- Ensure regular technical contact with MPU representative (User, QA, Validation, …), TS Head and sub department of Be EM (Automation, Maintenance, Validation…) and MSAT.
- Ensure Vaccines Primary Process, system and equipment understanding.
- Focus on performance of operations.
- Define and validate technical content of each support troubleshooting request with the different MPU.
- Provide support to "Asset Care" team: E-Ticket request, specific troubleshooting and equipment/components obsolescence assessment.
- Deep analysis of the problem / issue
- Propose the best action plan/solution in term of Quality, Timing and Price
- Close follow-up of the right Implementation of the solution
- Analyze the opportunities to improve internal process and system
- Select with his N+1 adequate outsourced resources for short-term need.
- Escalade to GLOBAL/MSAT, LOC's / MPU topics
- Assure that Global Guidance are integrated in LOC's documents
- Perform GEMBA and PSS
- Perform training package for specific technology
- Build internal capabilities to diagnose and solve primary process equipment issues (by Mentoring & Coaching)
- Provide adequate support for field inspections and follow-up of all remediation activities to retrieve the necessary information to update the specifications and capture the lessons learned with final accountability for the performance and reliability of these system.
- Review and participate in the improvement of the Global Engineering Standards, Technical Standards, to enhance standardization and simplification of design
- Support his N+1 to establish an annual report for their area of expertise based on KPIs or deviations related to maintenance, validation and Calibration by analyzing root causes, to identify problems and propose action plan.
- Provide expertise support to the CAPEX project managers resulting in optimal project execution.
- Act as Expert in his domain of competence on Internal and External Audit (L1,L2,L3,L4).
- Be fronter or support SME during inspection
- Review specifications in its discipline
- Provide the technical expertise to resolve the complex technical issues experienced by MPU regarding technical installations in its discipline
- Design the systems in compliance with GMP, EHS, FDA, GSK requirements
- Implements strict project control and reports to his management (Milestones follow-up and budget) and internal customer
- Execute Continuous Engineering Improvement projects in accordance with our quality Management System requirements
At GSK we provide a supportive working environment, and a range of development challenges and opportunities. We also offer competitive benefits and compensation packages designed to attract and to retain the very best. GSK is proud to promote an open culture, encouraging people to be themselves and giving their ideas a chance to flourish. GSK is an equal opportunity employer.
Once our pioneering treatments have been developed, they are manufactured to the highest standards and distributed across the regions that need them most. Accomplishing this as efficiently and quickly as possible can quite literally be a matter of life and death. So it's no wonder that more than 70% of our talented workforce is based within Global Industrial Operations - the essential business unit that manufactures and manages the entire vaccine supply process, from customer order to product dispatch on a global scale.
As the name suggests, it operates in a multi-national context across more than 17 sites around the world, working closely in tandem with colleagues from a variety of disciplines and professions.
The department is structured in operating units that focus on various aspects of the manufacturing and supply process. These include Industrialisation (overseeing the transfer of production from R&D to a commercial level), Supply Chain Management and Technical Services.
GSK is one of the world's leading research-based pharmaceutical and healthcare companies – is committed to improving the quality of human life by enabling people to do more, feel better and live longer.
GSK Vaccines is one of the world's leading vaccine companies, with a comprehensive portfolio of 39 vaccines for infants, adolescents and adults and 15 more in development. We have more than 16,000 people working worldwide to deliver nearly 2 (1.9) million vaccines every day to people in around 90% (172) of the world's countries.
For further information, please visit www.gsk.com.
You may apply for this position online by selecting the Apply now button.
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