Process 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.

Overview:

Process Engineer to provide technical process design
support for Bioprocess system on new Process Area CAPEX project.

Requirements

Responsibilities:

• Generation User Requirement Specification (URS) for
  assigned systems.
  
• Reviews and approves Basis of Design (BOD) and detail
  design of assigned systems i.e. PFDs, P&IDs, etc.
  
• Ensures procurement packages (bill of materials (BOM),
  datasheets, cutsheets etc) meet equipment specifications.
  
• Tracks HAZOP action items and ensures action items are
  incorporated into system design.
  
• Attends 30%, 60% and 90% model reviews ensuring systems
  meet operational, safety and ergonomic requirements.
  
• Reviews and approves system lifecycle documentation (FS.
  SDS, IO lists, etc) and ensures they meet requirements.
  
• Attends factory acceptance test (FAT) of associated
  equipment if required.
  
• Attends automation software bench FAT if required.
  
• Supervises and executes Site Acceptance Testing (SAT) and
  commissioning activities.
  
• Generates FAT, SAT and commissioning protocols for
  assigned equipment and ensures protocols meet specifications.
  
• Ensures Vendor Document Requirements (VDR) meet  requirements.
  
• Builds Preventative Maintenance (PM) tasks and spare
  parts lists on Computerised Maintenance Management System (CMMS)
  

Education and Experience:

• Requires BS/BEng in Chemical, Process or Mechanical
  engineering with 3 - 5 years related experience.  Direct experience with biopharmaceutical
  process equipment is preferred.  May
  substitute relevant experience for education.
  
• Experience with design and commissioning within
  biopharmaceutical sector would be desirable.
  
• Experience with DeltaV would be desirable