Senior Process Engineer HFX

Mission

As a member of the global MSAT – Manufacturing Technolgy department of Global GSK
Vaccines, the selected candidate will
– Collaborate with GSK global organization and Singapore project team members to ease
the vaccine process transfert.
– Act as the package owner of a super skid from purchase order to hand over to
Singapore site
– Deliver from details design phase to end of qualification some of the following equipment
into a super skid including its DCS system in closed collaboration with the automation
team:
o Fermentation
o Centrifugation
o Process vessel
o Cell grinder
o Precipitation vessels
o Ultrafiltration
o Chromatography

– The candidate will integer project strategy, supplier milestones and quality criteria. 50%
of the time will be spent in selected supplier premises or in Singapore at a later
stage of the project.

Profil

Required Experience & Knowledge
 Minimum of 10 years experience in the pharmaceutical industry or engineering office
 Experience into qualification and validation techniques and cGMP requirements
 Experience in different production scale with primary equipment
 Experience in facility design, process design
 Good organizational skills and ability to manage and identify priorities
 Good reactivity when facing challenges
 Continuous processing experience is an asset
 Automation and single use qualification experiences are an asset
Soft Skills
 Flexible thinking
 Flexibility for work shift due to time zone difference CET+7
 Analytical, logical and practical
 Open to other culture
 Capable of working as part of a multidisciplined team as well as an individual
 Autonomous
 Work according to GMP rules

Process Engineering, civil engineer, Mechanical Engineering discipline or relevant
experience in a similar industry or department.

Responsabilités

The position includes responsibility for all or part of the following steps :
 Respect the Singaporean regulation and the GSK vaccine specifications
 Meeting follow up with all stakeholders (internally and externally)
 Organization of coordination meetings addressing the project deliverables
 Follow the detailed design and manufacturing of the equipment for mechanical,
automation and single use parts
 Drive process review with automation engineer (Marked up P&IDs, FS, FDS,…)
 Ensure facilities utilities are designed according to equipment needs.
 Collaborate with QA and supplier to issue appropriate design GMP documents
 Drive internal workshop with stakeholder to ensure alignement and compliance to
regulatory requirements but also to keep planning on track
 Provide report and feedback on regular basis according to project definition to
internal GSK process engineer responsible inside global MSAT oragnisation
 Review and approve all design document from supplier with GSK responsible
concertation.
 Travel to supplier premises to inspect and ensure the manufacturing quality is as per
expectations
 Travel to Singapore when needed
 Responsible of testing definition and execution from FAT to SAT and IOQ
 C&Q coordination and execution, with the project manager, the users, C&Q team,
engineers and other disciplines associated within the project
 Guaranty EHS rule are respected during all project activities
 Perform Training to end-users and maintenance

 Hand-over the packages to end-users
 Ensure correct systems implementation through training, SOP writing and assistance
to the production team and al related GSK document.