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.

Bring
energy, knowledge, innovation to carry out the following:

•                 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 in Carlow.

Requirements

What skills you will need:

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