Senior Validation 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:

Looking for senior Validation Engineer with team lead
experience reporting to the Commissioning Qualification and Validation Manager,
day to day technical direction may be delegated to the Engineering Validation
Team Lead as required, and is responsible for fulfilling validation activities
in a GxP regulated environment,  including implementation of laboratory systems, new   manufacturing    equipment/processes    and    changes    to    existing equipment/processes.

Technical Operations group is responsible for creating
our drugs for use in clinical trials and for scaling production of those drugs
for the commercial market. These individuals build and maintain cutting -edge
manufacturing processes and sites, provide quality assurance and quality
control to ensure we meet regulatory standards, and procure the needed goods
and services to support manufacturing and coordinating the worldwide movement
of our drugs to patients.

Requirements

Responsibilities:

• In collaboration with plant support functions, assist
  with planning, set up and implementation of Analytical Instrument
  Qualification, Facilities, Utilities, Equipment (FUE) Qualification and Process
  Validation programs.
  
• Execute (protocol generation, execution, and final
  package preparation) Validation activities related to the various Validation
  disciplines e.g. FUE Qualification, CSV, New Product Introductions and Change
  Control.
  
• Develop validation plans for specific system
  implementation projects.
  
• Support the establishment of site validation policies,
  through development, generation and implementation of site validation master
  plans, guideline documents and standard operating procedures.
  
• Prepare and track to completion any assigned change
  requests, deviations, quality events and associated CAPAs.
  
• Develop and demonstrate an active approach to safety,
  industrial hygiene, environmental and regulatory compliance.
  
• Assist   with   preparation   of   regulatory   filings and   participation during regulatory inspections/partner audits.
  
• Maintain current knowledge of industry standards and
  regulatory requirements for products developed or manufactured, validation
  techniques/approaches and systems utilized
  
• Lead and represent validation in multi -departmental
  meetings and project teams.
  
• Identifies and implements improvements to the Engineering
  Validation systems.
  
• Coordinate   validation   activities   involving   cross -functional, multi -departmental   teams including:  Manufacturing,
  Process Sciences, Process Development, Quality Control, Quality Assurance,
  Regulatory Affairs, and others.
  
• Drug Product -specific. Drug Product experience is still a
  preference but we will look at other validation experience as well (e.g.
  Cleaning, Steam, Temperature Mapping).
  

Other duties as assigned