Lead Engineer, process (pharmaceutical)

该职位来源于猎聘 As the Lead Process Engineer, this role is responsible for

• Leading client discussions within process and facility design to assist the client to achieve their goals
• Feasibility studies up to detailed engineering
• Familiar with insulin Drug substance facilities design with specific emphasis in one or more of the following: upstream/downstream insulin processing, included media preparation, buffer preparation, Inoculum, seed expansion, fermentation producing, centrifugal separation, Harvest, purification process, CIP/SIP.
• Coordinates with project managers to determine project scope, complexity, and schedule for project development.
• Develops project execution plans (budget, milestones, deliverables and staffing plans) to deliver project on time, on budget and of the highest quality.
• Writes scope of work for process, utilities and manufacturing controls based on preliminary reviews with the client.
• Complete design deliverables for insulin process including, system schematic diagrams, BFD，PFD, mass balances calculation, black utility requirements and system P&IDs that include controls strategy, if appropriate.
• Process evaluation and optimization
• Development of URS, technical specifications, request for quotation, technical analysis and commercial evaluation of offers, follow-up of construction, pre-operational testing, installation commissioning and validation.
• Experience in design through qualification of stainless-steel fermenter, CIP/SIP unit, centrifugal unit, membrane filter unit, chromatography unit, ultra filter unit, freeze drying unit, fixed & mobile process vessels.
• Complete insulin process design for media preparation, buffer preparation, Inoculum, seed expansion, fermentation producing, centrifugal separation, Harvest, purification process, CIP/SIP.
• Familiar with upstream and downstream insulin process flow, personal flow, material flow and waste flow layout requirements
• Familiar with each of drug substance insulin process operation background and cleanness grade.
• Ensure completion of quality specifications and performance data sheets for process equipment and instrumentation.
• Make use of and participate in development of company design tools including process simulation and smart P&IDs (CAD, PDMS, Revit, plant 3D, Super pro, Schedule pro etc.).
• Establish and maintain excellent working relationships with clients and members of the Exyte design team.
• Collaboration in crossing-disciplinary teams
• Successfully interface with clients, project managers, and engineering professional and coordination between client and equipment suppliers.

Additional responsibilities

• Knowledge of China and oversea GMP (NMPA, ISPE, ASME BPE, EP, USP)
• HAZOP Studies when required.
• Familiar with pharmaceutical system validation guidelines.
• Support DQ review and design GMP review.
• Other tasks assigned by Department manager Professional experience & education
• Minimum of fifteen (15) years engineering experience and a minimum of ten (10) years in bioprocess design, preferably in the pharmaceutical and biotechnology industries.
• Experience in the life sciences (pharmaceutical, biotech, nutraceutical, etc.) is preferred.
• Sound knowledge of system design, applicable codes and cGMP’s as they affect process design and equipment specification and knowledge of pharmaceutical production
• Possesses a demonstrated ability for analytical thinking, an aptitude for structured problem solving, superior verbal and written communication skills as well as a strong work ethic.
• Must be able to build strong rapport within department and across Exyte disciplines.
• Travel may be required as projects are being executed at different parts of China.
• Knowledge of Good Manufacturing Practice (GMP)
• Knowledge of equipment design and system specifications, utility system calculations and energy optimizations
• Knowledge of installation, start-up and commissioning; handover of documentation activities
• Proficiency in spoken and written Chinse and English.
• Diligence to solve problems and finish the work in a structured manner
• Global mindset and enjoy working in a multi-cultural environment
• Result-oriented and have a well-structured approach to your work Specific skills & knowledge
• Process design (Life Science)
• Process equipment (Life Science)
• Design criterial (GMP, ISPE, ASME, EP, USP)
• Process Calculation
• Process Layout
• Design software
• Validation
• Quality Assurance
• Regulatory Affairs