Lead Process Engineer

• Analyze Customer User Requirements specifications
• Define technical solutions including analysis of process mass balance, equipment selection and sizing, drafting process and instrumentation diagrams.
• Write technical proposals including clarification and exclusion lists.
• Create Project Costing sheets including material and manpower costs
• Request, analyze and implement quotations for all main sub suppliers and include in technical proposal
• Develop Project schedules
• Perform Project Risk assessments
• Present and discuss technical solution with customer

• Contract review following customer order
• Magic project creation and maintenance
• Develop Project Quality Plan
• Complete basic design including process and instrumentation diagram, component lists and process functional specifications
• Obtain valid quotations for all materials and initiate orders with procurement.
• Cross functional communication, progress monitoring, co-ordination of sub supplier activities (e. g. mechanical fabricators, electrical fabricators and software companies).
• Progress monitoring, reporting and control
• Financial status monitoring, reporting and control
• Coordination of incoming goods inspection
• Assessing and resolving complex technical/process issues
• Coordination of Qualification/Verification activities at the various project stages (pre-FAT, FAT, SAT, IV/OV)
• Creation of technical documents and co-operate with Documentation team to assemble final technical documentation package.
• Project Management and co-ordination of Small and mid-size projects.
• On the job training for new team members
• Drive and Participate in Continuous improvement processes
• Chair/Execute daily visual management

• BSc/MSc or equivalent in Biochemical engineering, Process engineering, chemical engineering or equivalent. A higher degree or secondary degree in a related subject would be an advantage
• Adequate industry knowledge on biopharmaceutical processes, technologies, products and their applications and in-depth knowledge and experience on downstream systems.
• Minimum 7 years of experience in the design and engineering of process equipment Chrom, IC, PUPSIT and Bulk filling, filtration, separation and purification equipment (Single use technology, direct or tangential flow, filtration etc.) used in a upstream & downstream process.
• It will be preferred having 3 years of experience in PLC design or electrical design
• It will be preferred having 3 years of concept, knowledge and experience in system hardware validation work in which confirm what the team have designed and manufactured for the customer.
• It will be preferred experience of working with outside sub-contractors including mechanical fabricators, electronic fabricators, Software designers and automation experts.
• It will be preferred experience in qualification activities (FAT/SAT) for process equipment in the biopharmaceutical industry.

• Ability and willingness to work in a multinational and interdisciplinary team with necessary travelling.
• Proven experience and success working cross functionally with Commercial (Account Managers, Specialists, Regional Managers) technical teams, Marketing, Product Management and Senior Managers.
• Fluent Language skills in English.
• Knowledge and understanding of the current industry guidelines for designing, manufacturing, testing and documenting biopharmaceutical process equipment. (ASME BPE, GAMP, cGMP, ISPE, cFDA etc.)
• Ability to teach other team members from professional experience and detailed technical knowhow.

• To work safely and to comply with the company’s health, safety and environmental (HSE) policies and procedures.

Danaher