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:Provide process engineering services in support of the
design and commissioning & qualification of a significant expansion to an
existing bulk vaccine processing facility. The job-holder works with the Process Engineering Team as a client owner
representative to deliver Project Objectives.The Senior Process Engineer will manage cross functional
teams to deliver the following scope;Equipment package design, factory acceptance testing,
installation and commissioningPackages may include Product Vessels, Single Use Mixers,
Single Use UFDF skids & CIP/SIP skids.Department:Technology Center, Global Engineering
Solutions (GES)Position Reports to: Director EngineeringRequirementsResponsibilities:Support GES Process Lead to implement a Process Design
based on the scope of Process Requirements outlined in the project scope of
work.Lead cross-functional project teams to ensure project and
site stakeholder inputs and requirements are clear and reflected in C&Q
deliverables.Ensure all project stakeholders are informed and
consulted on key process suite activities and decisions.Monitor progress of process suite team milestones with
all team members and provide status reports to project Tiers and stakeholders.Oversee C&Q progression by a partner firm.Ensure Global and engineering standards, procedures and
practices are followed.Support GES C&Q Lead to coordinate preparation and,
at times, lead C&Q field execution.Develop and/or review system lifecycle documents
including Criticality and Risk assessments, FAT documentation, and C&Q
documentation.Manage installation / start-up / testing of process
systems through OQ completion. Interface
with cross-functional team to ensure systems’ post-OQ (PQ, PPQ) readiness.Liaise with stakeholders, equipment vendors, business
partners, and SMEs at other sites within the Manufacturing Network as required
to support Project.The job-holder will also undertake Project Engineering
duties including:preparation of project related deliverables such as
schedules, work plans, equipment cost trackingcoordination of project activities between stakeholders Education/Experience Requirements:Minimum qualification B.Sc. or M.Sc./ M.Eng Degree in
Chemical or Biochemical Engineering or equivalent discipline; equivalent is
defined as a Biotechnology or Industrial Chemistry Degree with basic the
elements of chemical/biochemical engineering fundamentals as applied to
biotechnology/bioprocessingMinimum of 8 years post academic process engineering
experience in relevant biopharmaceutical processing design, construction &
start-up environment. Demonstrated ability to lead / influence teams in a
matrix team environmentExcellent communication/presentation/organizational
skillsIn depth understanding of process engineering and
technologies pertinent to unit process and utility operations for a bulk
vaccine/biologics processing facility.Knowledge on the application of single use technologiesKnowledge of DCS/PLC process control platforms and
industry SDLC methodology such as Delta V.#LI-KV2