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Downstream Process Design & Equipment Lead
A Process Engineer with previous relevant experience is required to provide client side design input from the Detailed Design through to CQV execution stage of a Bulk Drug Substance (BDS) Facility and supporting infrastructure. The Primary area of responsibility shall be “Downstream, Purification Pre-Post Viral and Buffer Prep Area and Equipment Design”.
• To support the Company’s client side design team in its efforts associated with the delivery of the greenfield BDS Facility
• To support the client side design reviews in the area of Purification Operations, with particular responsibility for Buffer Prep / Chromatography / UFDF / VF-DF start-up operations.
• To participate in cross functional package, area, or overall design teams as required in support of the Company’s overall design goals and expectations
• To support the IPD and EPCM teams to deliver process equipment packages and stick built systems to the required quality and per schedule
• To participate in vendor and IPD design reviews, model reviews, etc., and to input on technical elements of the design
• To execute P&ID, URS, Specification and other reviews associated with Buffer and Purification operations
• To provide input and assistance to both Automation and CQV in relation to Buffer / Purification operations
• To act as a secondary back-up to a colleague Process Engineering Area Lead.
• To participate in the design reviews and specifications review of any Vendor Package Equipment
• Provide SME assistance for FAT’s / SAT / CQV activities at various locations as required
• Co-ordination of system turnover with the CQV and Construction teams
• Degree level qualification in chemical, electrical or mechanical engineering, or equivalent.
• Minimum of 10 years of experience in GMP pharmaceutical design / build / commission / start-up with direct responsibility for Engineering Documentation, Project Execution or Facility Design.
• Experience with design, construction or commissioning of a drug substance, drug product or finished product facility.
• Direct experience in a similar scale project of Buffer / Purification Operations
• Experience of Validation /Verification / CQV of GMP equipment or processes would be beneficial.
• Demonstrated ability to organize and lead a multifunctional team in support of defined objectives.
• Ability to constructively challenge, defend and present technical aspects of design and commissioning.