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 PropositionEmployees 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:You will join our Project Engineering Group (CPEG), part
of the larger Technical Engineering Department with responsibility to lead an
integrated project team in delivering the project business case.
Responsibilities include but is not limited to: Process improvements, capital
projects and Lean projects across multi-disciplined functions which may also
require global and network support and collaboration.RequirementsRole Functions:Manage projects from scope development, design,
build/install and qualify through to handover to operations for key Technical
Engineering projects.Maintain contact with the Project Sponsors to ensure
engineering solution development remains aligned with the project’s business
case.Responsible, with the Project Manager, for the
development and maintenance of the scope, budget and timelines. Adequately
resource core team in support of scope and schedule targets.Coordinate and present of the typical project Stage Gates
to off-site Capital Approval Committee.Use scientific, product and process understanding as a
basis for developing risk-based approaches to investigations and
troubleshooting that will feed into future projects.Develop project scope, cost and delivery time schedule
for all Tech Eng projects, working and collaborating closely with Technical
engineering leads to ensure integration into ongoing Validations and/or
Technical transfers.Collaborate closely with cross functional teams to
establish scope in improvement projects as we ramp up to a fully commercial
site.Act as a subject matter expert on: equipment design and
qualification; assisting in C&Q execution planning; system boundary
definition, system level and component criticality impact assessments, use of
quality risk management, User Requirement Specs and requirements traceability
matrices, Document Mgt. Systems, FAT/SAT and C&Q protocol development,
project implementation.Sponsor and foster lean six sigma and standard work
within the technical engineering Team (e.g. Structured Root Cause Analysis,
Statistical Process Control, Data driven decision making).Drive and support continuous improvement by active
participation in projects, system failure investigations and investigation
reports, execution/development of change control, and contribution to Kaizen
events as appropriate. Perform root cause analysis of system failures,
substandard performance, using standard tools and methods, to resolve machine
and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.; implement
subsequent corrective action through the change management system.Integration of Computer Systems Validation activities, in
collaboration with Automation/IT partners, into required projectsDrive collaboration between groups within the Technical
Engineering function proactively looking for synergies and innovative ways of
doing work.Constantly assess our systems and processes to see what
improvement we can make to work smarter and more efficiently while all the time
being compliant.Act as a liaison with both global engineering services
and facilities as well as specialist vendors to deliver projects on time and in
full as required by the business.Work collaboratively to drive a safe and compliant
culture.May be required to perform other duties as assigned. Experience, Knowledge & Skills:Experience as a Capital Projects Team Lead for large
capital projects (>$5MM) preferable.Considerable experience in a comparable role; would
typically have experience operating as a senior professional and adding
considerable value to the business. Would have process engineering and/or
validation experience in a sterile manufacturing environment and have a proven
track record in leading a technical team of engineers / scientists through
sustaining operations and technical transfer projects. Experience in leading
through change would be an advantage.Knowledge of regulatory/code requirements to Irish,
European and International Codes, Standards and PracticesIn depth knowledge and experience of Sterile filling
processes and equipment especially aseptic processingExperience of executing and/or managing through equipment
and process design and validation in a sterile environmentGood shipping/Filter/Cleaning validation knowledge
requiredKnowledge of QbD/CPV desirableExcellent report, standards, policy writing skills
requiredAutomation and MES knowledgeProficiency in Microsoft Office and job related computer
applications requiredLean Six Sigma Methodology experience desiredExperience in audit preparation and execution desiredHaving a strong safety ethosExcellent communication, presentation and interpersonal
skills, to interface effectively with all levels of colleagues and with
external customers in a team orientated mannerUnderstand the specific responsibilities ,functions as
they relate to one’s own department as well as the network governance groupsExcellent people management skillsProven record in planning and basic project management of
a team to deliver on time/schedule and costProven contractor and vendor managementFocus on Customers and PatientsQualification:Bachelor Degree or higher preferred; ideally in a
Science, Engineering or Other Technical discipline Green Belt preferable#LI-AM1