Crest Solutions are an engineering and software company that supply and support the resourcing of engineers, analysts, specialists and other professionals in this field. We are home to a vibrant group of professionals, working together to deliver to our clients. As a Gold Certificated company in the NSAI Excellence Through People scheme, Crest Solutions strives to guide many of Ireland’s most successful organisations to become more efficient, productive, flexible, competitive and innovative, through the development of great people.

Principal Responsibilities:

• To support the 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 CIP, Parts washers, Autoclaves, benchtop and production support equipment
• To support the client side design reviews in the area of production support operations
• To participate in cross functional package, area, or overall design teams as required in support of overall design goals and expectations
• To support the 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 CIP and production support systems
• To provide input and assistance to both Automation and CQV in relation to CIP and production support operations
• 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

Qualifications:

• Minimum of 5 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
• 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.

Education:

• Degree level qualification in chemical, electrical or mechanical engineering, or equivalent.