Process Engineering Specialist - Wavre, België - 1849 GlaxoSmithKline Biologicals S.A.

Beschrijving

Job purpose :

As a Process Engineering Manager, you are:

·Providing support and expertise 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.

·Delivering equipment in the following technologies:

oAseptic Filling lines (Vials, Syringes, Tubes, BFS)

oRABS

oIsolator technologies (Bulk, Formulation, Filling and QC testing)

oBiosafety Cabinet - Leak testing machine - - Stopper processor

oVial washing / Siliconization - - Sterilization tunnel

oGloves Tester

oRoom Decontamination (Dryfog)

oRobot & AGV

·Challenging and supporting project and asset care teams on complex and Belgian transversal issues.

·Proactively ensuring and safeguarding 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

·Supporting all Belgium GSK Vaccines sites concerning technical troubleshooting, and hands on training based on industry best practices

·Acting as fronter or support during internal and external inspection

In this role you will have the following responsibilities:

·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 Secondary 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

·Act as Expert in his domain of competence on Internal and External Audit (L1,L2,L3,L4).

·Be fronter or support SME during inspection Accountability:

·Provide expertise support to the CAPEX project managers resulting in optimal project execution.

·Review specifications in your discipline

·Design the systems in compliance with GMP, EHS, FDA, GSK requirements

·Implement strict project control and report to your management (Milestones follow-up and budget) and internal customer

·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 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 secondary 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 N+1 in establishing 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 the technical expertise to resolve the complex technical issues experienced by MPU regarding technical installations in your discipline

·Execute Continuous Engineering Improvement projects in accordance with our quality Management System requirements Leadership:

oEnsure the retention and keep the knowhow internally

oManage some Outsourcing mission as coordinator

·Master's degree in Engineering sciences with strong technical and aseptic background

·A previous experience in the required domain

·Broad knowledge of Technologies Secondary processes.

·Deep and specific technical knowledge of Process Aseptic Based Vaccines production (Filling line, Isolator, Lyo,...)

·Expertise in cGMP and good knowledge of Material Sciences (Stainless steel, welding, plastics,...)

·Expertise in Validation Methodology, Secondary equipment and Bio-safety

·Extensive knowledge of GSK Vaccines organization (QA-QC[1]Manufacturing-Regulatory-Validation)

·Highly effective at influencing internally and externally

·Highly effective communication skills both verbal and written

·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)

If you have a disability and require assistance during the course of the selection process, you will have the opportunity to let us know what specific assistance you require in order to make suitable arrangements.

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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