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:

Our Carlow site are excited to offer a fantastic
Engineering Specialist (Validation) opportunity for candidates interested in a
new challenge in a cGMP regulatory environment. The successful candidates will
support several aspects of Validation.  The roles available that will require experienced, energetic and
committed engineers are in the following areas:

• Sterilisation – Autoclaves, SIP of vessels
  
• Cleaning – Parts Washer and CIP of vessels
  
• Isolator (Filling, Sterility & Material Transfer
  isolators) - HVAC, VHP, E -Beam and Depyrogenation systems
  
• Controlled Temperature Units (CTU) – Temperature/Humidity
  Mapping
  
• Filter Validation
  
  

Requirements

Role Functions:

• Design/Author/Review/Approve/Execute
  qualification/validation documentation and cycle development studies in line
  with the standard approval process.
  
• Design/Author/Review/Approve/Execute
  Execution/development of change controls.
  
• Resolving technical issues encountered during study
  execution.
  
• Engagement with Production, Maintenance and Quality
  representatives in the assigned area of operations during execution of Cycle
  Development & Performance Qualification activities.
  
• Technical input into quality notification by
  authoring/reviewing/approving investigations.
  
• Perform root cause analysis of system failures,
  substandard performance, using standard tools and methods, to resolve machine
  and system issues.
  
• Support continuous improvement through Lean Six Sigma
  methodologies.
  
• Serve as validation representative for cross functional
  projects and represent the validation team at global technical forums
  
• Drive compliance of Global Policies, Procedures and
  Guidelines, regulatory requirements and execute current Good manufacturing
  Practices (cGMP) in the performance of day -to -day activities and all applicable
  job functions, ensuring consideration of the impact on GMP and compliance and
  decisions made.
  
• Accountable for compliance via documentation completion,
  risk assessments, closing out corrective actions, participation in audits and
  inspections and proactively highlighting any issues around compliance
  
• Supporting regulatory audits and submissions as required.
  
• Work collaboratively to drive a safe and compliant
  culture.
  
• May be required to perform other duties as assigned.
  

Experience, Knowledge & Skills:

• In order to excel in this role, you will more than likely
  have considerable experience in a comparable role, with experience operating as
  individual contributor adding value to the business in a GMP manufacturing
  setting, as well as the following qualifications/skills:
  
• Relevant technical qualification(s) in Applied
  Pharmaceutical / Biological / Chemical sciences or applied Technical /
  Engineering qualification, the successful candidate will also have a proven
  track record in delivering excellence.
  
• Knowledge of CTU equipment qualification
  
• Knowledge of thermal mapping equipment
  
• Thermal mapping skills
  
• Exception / Deviation Management and Change Control.
  
• Demonstratable experience of leading technical related
  projects.
  
• Knowledge of process monitoring systems, automation
  systems (DeltaV), operational intelligence & data systems (Pi System)
  within a GMP manufacturing environment would be beneficial and desirable
  
• Evidence of continuous professional development is
  desirable.
  
• Knowledge of regulatory/code requirements to Irish,
  European and International Codes, Standards and Practices.
  
• Ability to analyse and interpret complex data, and link
  to equipment performance and out of specification findings as appropriate.
  
• Report, standards, policy writing skills required.
  
• Equipment and process validation.
  
• Sterile Fill -Finish processes and equipment.
  
• Proficiency in Microsoft Office and job -related computer
  applications required
  
• Excellent communication, presentation and interpersonal
  skills, to interface effectively with all levels of colleagues and with
  external customers in a team orientated manner.
  

Knowledge and experience of the below areas will be
considered advantageous:

• Equipment Periodic Validation
  
• Equipment Validation Lifecycle
  
• Project Management Skills/Qualification
  
• Filter Validation & Container Closure Validation
  
• Autoclave/SIP Sterilisation Validation
  
• Dry Heat Sterilisation
  
• Isolator Qualification
  
• Vial and Syringe Processing Technologies
  
• Temperature Mapping
  
• Cleaning Validation
  
• The successful candidate will be required to work both
  independently and in a cross -functional team to accomplish validation project
  objectives. Works with moderate work direction and is skilled and knowledgeable
  to the position.
  

Qualifications & Education:

• Relevant technical qualification(s) in Applied
  Pharmaceutical / Biological / Chemical sciences or applied Technical /
  Engineering qualification, the successful candidate will also have a proven
  track record in delivering excellence.