BE2225
DPS Group Belgium is looking for a senior process engineer with single use experience for a long-term pharmaceutical project in Brussels.
DPS
DPS is a leading Project Management and Engineering Company serving industries around the world for over 40 years. Specialising in the life sciences, medical technologies, oil and gas, energy and advanced technologies sectors, the Group provides consultancy and process engineering expertise to leading clients globally via their four operating business units.
One of these business units is DPS Contract Services. They provide contingent contract and temporary labour to the existing customer base within the engineering field for clients in the scientific and technology sectors throughout Europe via their network of offices located in Ireland, UK, Belgium and Holland. They also provide engineering staff to the various DPS divisions on a contract basis.
Role
CONTEXT
New Greenfield Project of a new manufacturing Gene Therapy building for biologicals production; Large scale investement of a fully process single use facility
PROFILE
-15+ years of relevant experience in large scale EPCM Projects in the pharmaceutical industry
-In-depth technical experience in a regulated environment with knowledge of gene therapy, biologicals, pharmaceutical and engineering operations
-Expertise in single use systems within the pharmaceutical industry
-Large experience in basic/detailed design, equipment installation and commissioning
-Supporting qualification and validation activities
-Good understanding of EHS (Environment, Health and Safety) and Quality aspects
TECHNICAL SKILLS
-Experience with EPC (Engineering, Procurement and Construction) and EPCM (Engineering, Procurement and Construction Management)
-Strong background within manufacturing DSP (downstream) process equipment (Single use UF/MF filtration skids, Single use Chromatography skids, Single use TTF/VRF, Single use mixer)
-Good knowledge of Media buffer production equipment (single use mixer, single use tote, single use aseptic connections, single use bags)
-Ability to interpret and set-up P&ID (Piping & Instrumentation Diagrams) and PFD (Process Flow Diagrams) is required, as well as mass balances.
-Ability to lead & review PED (Pressure Equipment Directive) is an important asset
-Ability to act as technical process expert during HAZOP (Haz931918.291405ard and Operability study) / QRA (Quality Risk Analysis) / FMEA
-Knowledge in qualification & validation approaches (specially ASTM E2500) is highly relevant
-Strong knowledge of cGMP/GLP regulations, ICH, FDA CMC, ISPE and PDA Guidance Documents is preferred.
-Experience in large and complex projects as well as both formal and informal leadership / coordination
TASKS:
FEASIBILITY STUDY/Conceptual design
-Analyse and challenge technical solution presented by Engineering office
-Verify budget estimate generated by Engineering office
URS
-Review the URS provided by the Engineering Office in order to ensure all User requirements are fully respected
-Include all technical requests in the URS for the commissioning and qualification.