Process Engineering Specialist - Wavre, België - GSK

GSK

Geverifieerd bedrijf

Wavre, België

2 weken geleden

Geplaatst door:

Sophie Dubois

beBee Recruiter

Beschrijving

Site Name:
Wavre

Posted Date:
May

_ Process Engineering Manager_:

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:
Aseptic Filling lines (Vials, Syringes, Tubes, BFS)
RABS
Isolator technologies (Bulk, Formulation, Filling and QC testing)

Biosafety Cabinet

Leak testing machineStopper processor
Vial washing / SiliconizationSterilization tunnel
Gloves Tester
Room Decontamination (Dryfog)
Robot & 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:

Daytoday Operations: _
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:
New equipments:_
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 followup and budget) and internal customer
Performance & Troubleshooting:_
Propose the best action plan/solution in term of Quality, Timing and Price
Close followup of the right Implementation of the solution
Analyze the opportunities to improve internal process and system
Select with N+1 adequate outsourced resources for shortterm 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 followup 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:
Ensure the retention and keep the knowhow internally
Manage some Outsourcing mission as coordinator

**_

Please note that depending on your profile and experience we may offer to employ you in the grade different from the position grade.

_****_
Why you? _**- Qualifications & Skills:_

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 Biosafety
Extensive knowledge of GSK Vaccines organization (QA-QC[1]Manufacturing-RegulatoryValidation)
Preferred Qualifications & Sk