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:
New exciting opportunity now exists on our Carlow Site
for a Process Engineer to join the Process Engineering Group on site and report
to the Technical Engineering Manager
Our new team member will serve as technical support for
new product introduction (NPI) and commercial manufacturing and will
participate and/or lead cross functional or single function teams including
liaising with vendors or above site groups. You will typically have prior
related work experience; ideally in manufacturing, preferably GMP Setting but
we will consider applicants from other working environments as long as they
have technology transfer experience
Knowledge of process monitoring systems, automation systems
(DeltaV), operational intelligence & data systems (Pi System) within a GMP
manufacturing environment would be beneficial and desirable but not a necessity
for this role
Our Engineers support internal and external manufacturing
operations remain operational, continuously improve and innovate. With our
extensive range of facilities and environments, our Engineers have
opportunities across many diverse areas including Biological, Chemical,
Automation, Capital Projects, Maintenance, Safety, Process Development,
Technical Services, Utilities and Validation.
Requirements
Responsibilities:
* Design/Author/Review/Approve/Execute
qualification/validation documentation and process development studies in line
with the standard approval process
* Design/Author/Review/Approve/Execute
Execution/development of change controls
* Contribution to Kaizen events as appropriate
* Technical input into quality notification by
authoring/reviewing/approving investigations
* Execution of equipment/qualification validation programs;
including re -qualification and re -validation
* Support continuous improvement through Lean Six Sigma
methodologies
* Perform root cause analysis of system failures,
substandard performance, using standard tools and methods, to resolve machine
and system issues
* Serve as technical engineering representative for
internal technical group discussions and represent technical Operations Carlow
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 action, participate in audits and
inspections and proactively highlighting any issues around compliance
* Work collaboratively to drive a safe and compliant
culture in Carlow
* May be required to perform other duties as assigned
Skills Required:
* Bachelor's Degree or higher preferred; ideally in a
Science, Engineering or other Technical discipline
* Min 3 years experience ideally in manufacturing,
preferably GMP Setting
* Demonstratable experience of leading technical related
projects
* Evidence of continuous professional development is
desirable
* Knowledge of process monitoring systems, automation
systems (DeltaV), operational intelligence & data systems (Pi System)
within a GMP manufacturing environment would be beneficial and desirable but
not a necessity
* Knowledge of regulatory/code requirements to Irish,
European and International Codes, Standards and Practices
* Report, standards, policy writing skills required
* Equipment and process validation
* Sterile filling 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
* Hybrid role once successful completion of training,
occasional shift support as required based on program needs