Biotech Engineering Design And Construction
"engineering design and construction–sourcing best practices for vaccines/biotechnology industry"
in-house vs. Outsource:
• how do companies deal with the engineering offices category for vaccines/biotech categories across germany, italy, hungary, uk and usa? (in-house or outsource)?
• what is the widely adopted execution model for this category? (complete in-house, epc, epcm, gc+e&a etc.)
• what are the key dependent factors considered in this regard to decide on using the outsourcing model?
O type of engineering and construction services (basic scheme/design, procurement, construction management and contracting etc.)
o package (groundworks and external works, cleanroom, hvac, building services, electricity, process equipment etc.)
• how do companies source their engineering office services across germany, italy, hungary, uk and usa? (centralized or decentralized)
engagement strategy and contracting:
• how do companies engage with the engineering office suppliers?
O global/regional/local engineering offices
o single/multiple engineering offices
o factors that determine the choice of strategy
• what are the contracting models followed with these suppliers? (reimbursable, lumpsome etc.)?
• what is the duration of the partnership between the clients and the engineering offices?
• what is the cost structure for the key disciplines used in the engineering offices category across germany, italy, hungary, uk and usa?
• who are the top engineering office companies across germany, italy, hungary, uk and usa+4 Other Responses
We are a biotech company ( locate in san francisco ca ) and are approaching venture capitalist and angel investor. We are looking for a ceo/partner to catapult the company into the next growth phase.
experience and background in biotechnological company and global sustainability, extensive global experience for growth and deployment.
Strong background of raising capital, strong negotiation and deal structure skills are required
please apply.+22 Other Responses
the manufacturing operations support engineer will provide on floor technical support to manufacturing operations, work with investigation teams in solving complex manufacturing issues, identify opportunities to improve manufacturing processes and cgmp documentation and analyze manufacturing process control data.
• provides daily on-the-floor technical support to manufacturing operations.
• write and review batch records.
• identify areas of process risk identify, assess, and implement risk mitigation strategies.
• tracks, trends, and communicates process performance.
• leads process validation and verification efforts.
• possesses an understanding of the principles related to the validated states of the process and process equipment.
• promote “right first time” philosophy for all manufacturing activities.
• provide technical training to manufacturing personnel.
• participate in change controls and product deviation investigations.
• ensures manufacturing staff identify and document events that deviate from normal operation.
• provide technical support to deviation investigations.
• completes investigations, reports, and proposes capa for minor deviations.
• supports plant floor continuous improvement initiatives (process and value stream mapping).
• supports the creation manufacturing sop’s that ensures manufacturing operations stay aligned with the validated process.
• bs in chemical or biochemical engineering (or similar) with 0-2 years manufacturing floor experience.
• demonstrated understanding of biologics manufacturing, scale-up and validation principles.
• excellent problem solver and ability to generate innovative solutions to broad range of issues.
• good understanding of experimental design and statistical process evaluation.
• ability to explain complex technical issues to other functions in clear and understandable terms.
• familiarity with one or more upstream or downstream process unit operation design typically used in biotech manufacturing (cell expansion, fermentation & cell culture, harvest / clarification, purification).
• previous experience with process or equipment validation
• ability to evaluate new technologies/techniques.+11 Other Responses