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.
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Engagement Type: Time-and-materials
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Location/Mode: 5 days on site (flexibility as agreed with Manager)
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Start Date: Immediate
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Duration: Q1 (2028) approx
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Hours/Shift: 40 hours per week
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Looking for LTD candidates who are based in Ireland
Scope and Core Responsibilities:
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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.
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SME for commissioning and qualification of DeltaV system
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Responsible for DeltaV commissioning and qualification activities, including loop testing, onsite commissioning and site testing through to OQ complete
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Manage Automation change requests that are a product of CQV activities
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Manage stakeholders to the DeltaV commissioning and qualification process
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Partner with Computer System Validation (CSV) and Digital Data Quality (DDQ) teams to ensure compliance with applicable standards and policies.
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Partner with internal Digital departments ensuring standard and secure implementation in line with Standards
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Deliverables
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DeltaV commissioning plans and execution records.
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Loop test documentation and completion reports.
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Site testing and commissioning records.
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Operational Qualification (OQ) execution evidence and reports.
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Automation change request assessments and implementation records.
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Validation and qualification documentation supporting CSV deliverables.
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Risk assessments and issue resolution documentation.
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Stakeholder and project status reports.
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CQV completion and handover documentation.
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Compliance and audit support records.
Required Qualifications and Competencies:
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BS in Engineering, Computer Science, or other technical degree.
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Training completed in DeltaV standard.
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5 or more years of experience required in DeltaV application.
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3 or more years of experience required in site-based Commissioning role in GMP environment.
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Proven record of proficiencies associated with commissioning and qualification of complex systems on capital projects.
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Understanding of cGMP's, SDLC methodologies and principles.
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Excellent facilitation, problem solving, and decision-making skills.
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Proven ability to work in cross functional teams.
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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:
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Spray drying experience would be advantageous.
Onboarding Checklist
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Approve and submit access requests for Kneat Gx/eVal, MEDS (Coordinator access), SharePoint sites, and PIMS. Provide expected provisioning timeframe and contact owner.
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Provide list of required compliance checks (right-to-work, background/security checks) and initiate as required.
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Resource: Confirm receipt of start details, first-day schedule, and reporting line. Acknowledge compliance requirements.
