Senior CQV Engineer

About PSC Biotech

Who are we?

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.

Summary:

• Objective: Reporting to the Digital  Project Lead, specifically responsible for
  Automation CQV Support.
  
• Engagement Type: Time-and-materials
  
• Location/Mode: 5 days on site (flexibility as
  agreed with Manager)
  
• Start Date: Immediate
  
• Duration: Q1 (2028) approx
  
• Hours/Shift: 40 hours per week
  
• Looking for LTD candidates who are based in Ireland
  

Requirements

Scope and Core Responsibilities:

• Required to work closely with the Digital  teams responsible for the full Automation and
  IT scope and with vendors / partners with responsibility for commissioning and
  qualification of DeltaV DCS.
  
• SME for commissioning and qualification of DeltaV system
  
• Responsible for DeltaV commissioning and qualification
  activities, including loop testing, onsite commissioning and site testing
  through to OQ complete
  
• Manage Automation change requests that are a product of
  CQV activities
  
• Manage stakeholders to the DeltaV commissioning and
  qualification process
  
• Partner with Computer System Validation (CSV) and Digital
  Data Quality (DDQ) teams to ensure compliance with applicable standards and
  policies.
  
• Partner with internal Digital departments ensuring
  standard and secure implementation in line with Standards
  
• Deliverables
  
• DeltaV commissioning plans and execution records.
  
• Loop test documentation and completion reports.
  
• Site testing and commissioning records.
  
• Operational Qualification (OQ) execution evidence and
  reports.
  
• Automation change request assessments and implementation
  records.
  
• Validation and qualification documentation supporting CSV
  deliverables.
  
• Risk assessments and issue resolution documentation.
  
• Stakeholder and project status reports.
  
• CQV completion and handover documentation.
  
• Compliance and audit support records.
  

Required Qualifications and Competencies:

• BS in Engineering, Computer Science, or other technical
  degree.
  
• Training completed in DeltaV standard.
  
• 5 or more years of experience required in DeltaV
  application.
  
• 3 or more years of experience required in site-based
  Commissioning role in GMP environment.
  
• Proven record of proficiencies associated with
  commissioning and qualification of complex systems on capital projects.
  
• Understanding of cGMP's, SDLC methodologies and
  principles.
  
• Excellent facilitation, problem solving, and
  decision-making skills.
  
• Proven ability to work in cross functional teams.
  
• This is a site-based role. The successful candidate may
  sometimes be required to attend meetings at Vendor premises or other sites as
  required.
  

Desired:

• Spray drying experience would be advantageous.
  

Onboarding Checklist

• Approve and submit access requests for Kneat Gx/eVal,
  MEDS (Coordinator access), SharePoint sites, and PIMS. Provide expected
  provisioning timeframe and contact owner.
  
• Provide list of required compliance checks
  (right-to-work, background/security checks) and initiate as required.
  
• Resource: Confirm receipt of start details, first-day
  schedule, and reporting line. Acknowledge compliance requirements.