该职位来源于猎聘 Duties& Responsibilities

Deliver

High Level Quality Pharma Process Technology and technical GMP-Consulting know how in LS for:

Win and deliver projects for Exyte in APAC in the first line

Biotech customers

CD-Team in APAC region

Training and support of customers, Exyte team to win and execute projects, guarantee business success and growth

Build long lasting customer relationship

Develop For The LS CD-Team

Front

End design studies for (Feasibility Studies, Site Master Plans, Concept and Basic Design) of all pharmaceutical production technologies on high level or associated level as required

Analytical project analyzation for safety, complexity, costs, schedule, risks

Implement design strategies for fast track and EPC execution model for Exyte

Process

Technology integrated Facility / Building solutions in corporation with the Process Architect

Determining the associated construction budget costs and project schedule during the programming and design phase

Show

/ develop process technologies incl. facility under GMP requirements for

Lean or Continuous Manufacturing, Small Batch facilities

Analyse and address technical issues but also elaborate solutions for existing biotech technology (Brown Field) facilities or Greenfield projects demands in project reports and drawings

Second opinion of existing designs by third parties or internally

Organize and execute GMP risk assessments

Requirements

Interpretation and integration of product specifics, commercial product names, quantity into required production capacities, GMP layouts, facility sizes and project cost benchmarking Developing design and engineering solutions around the process and entire facility as unique selling proposition for Exyte Drive and develop out of the entire facility GMP-Layout self-performance skid solutions Develop for Biotech Industry demands modular facility solutions (f.e. KBio) Benchmarking production and operational costs, Production head count calculation, develop facility efficiency benchmarks Determining and defining sustainability targets and solutions for maximum cost and energy savings to bring clients production facility in a competitive position Review of the design of pharmaceutical layout and solutions produced by other team members internally or third parties, for GMP and technical compliance with specified and contracted client / customer requirements Review of all design and tender documentation Implementing the design checklists and tracking progress Arranging external and internal design reviews Taking part defined monthly client meetings Compiling lessons learned internally and with client Formulating any necessary recovery plans relating to:

Design

Cost

Schedule

Organizing with clients technical GMP-Audits and pre- authority consulting activities Mentoring of the Senior Engineers with the intent of securing properly trained personnel to ensure the continual expansion of the company Develop design documentation as per Deliverable List eg Process Flow Diagrams,

Piping and Instrumentation Drawings, System Layouts, Equipment and

Instrumentation data sheets Involved in preparation of tender document and tendering activities (tender preparation, tender interview / clarification meetings, evaluate proposals submissions and Tender Recommendation Report preparation) Perform engineering reviews on vendor documentation to ensure compliance and completeness in technical scope Brief

Process Supervisors on the project scope and ensure system complete on schedule Requirements:

Master of Science in Biotech Degree or Diploma of Biotech Process Engineering

Degree (or equivalent) in Chemical Engineering or a related subject 10-15

years professional related experience in Design / Engineering and construction of entire classical Biotech Production process in Cell culture, Vaccines mainly at external engineering contractor side 8-10

years dedicated knowledge in process know how for none potent and high potent Biotech products (Conjugates) manufactured under and filled under containment conditions 8-10

years experiences as dedicated Project manager Experience in Fast Track project execution Experience with designing and handling coordination of Life Science projects especially in the GMP-regulated classical Pharma, Biotech, Food and

Nutrition industry Deep and senior understanding of biotech GMP related process technology and process design 10

years’ experience in Biotech technology Engineering for different process and facility applications 10

years’ experience in a Senior Mechanical Engineer position of design and construction 5-8

years’ experience on fast track projects and different contract delivery models