CQV Engineer

1 month ago

Dublin, Ireland PSC Biotech Full time
  • Industry Pharma/Biotech/Clinical Research
  • Work Experience 5+ years
  • City Dublin
  • State/Province Dublin
  • Country Ireland
Job Description

About PSC Biotech

Who we are?

PSC Biotech is a leading Biotech Consultancy firm founded in 1996, headquartered in Pomona, California, USA, with Global operations in Ireland, India, Singapore, Australia and the US, serving 350 clients in more than 23 countries worldwide. We provide cloud-based software solutions for Quality Management and Regulatory Inspections, pharmaceuticals contract manufacturing professionals, and metrology services to our clients.

‘Take your Career to a new Level’

PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling point which includes the opportunity to work with the most talented cohort of like-minded professionals operating in the Pharma/ Biotech Industry. We offer a permanent contract of employment giving exposure of working in Top Pharmaceutical client sites in a diverse-cultural work setting.

Employee Value Proposition

Employees are the “heartbeat” of PSC Biotech, we provide unparalleled empowering career development though Learning & Development in-house training mentorship through constant guidance to facilitate career progression. We believe in creating high performing teams that can exceed our client’s expectations with regards to quality of all scalable and business unit deliverables, staying under budget and ensuring timelines for our deliverables are being met.

Overview:

· Commissioningand Qualification (C&Q) engineer for various capital projects. Ensure theC&Q activities associated with various capital projects are completedsafely, as per schedule and in compliance with GMP and Quality Requirements.

Requirements

KeyResponsibilities:

· Coordinatesand Supervises all C&Q activities on their assigned projects.

· GenerateC&Q planning documents detailing overall project strategy.

· Developsthe master list of project C&Q test documents and activities.

· Generatesall C&Q summary reports.

· Ensuresthe C&Q schedule is developed and maintained.

· Generationof all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&QSummary Report)

· ManagesDaily C&Q coordination meetings.

· Responsiblefor Overall Tracking and Reporting of C&Q status and risks/issues.

· EnsuresStartup of equipment/utilities is completed in a safe and coordinated manner.

· Assistin the development of User Requirement Specifications (URS’s) and Quality

· RiskAssessment for Equipment and Automated Systems (QRAES)

Education/ Experience:

· 6+years’ experience in Engineering or Commissioning and Qualification Management

· Technicalqualification at third level or equivalent in Engineering.

· Extensiveknowledge and demonstrated experience managing Commissioning and

· Qualificationfor Pharmaceutical / Biotechnology projects preferred.

· Knowledgeof safety, GMP and environmental regulatory requirements.

· Demonstratedstrong Communication and Leadership skills.

· Demonstratedability to collaborate with senior stakeholders to achieve optimal outcomes.

· Strongunderstanding of a risk‐based approach to commissioning and qualificationwithin the biotechnology industry.

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