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:Our Engineers help ensure that 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.The External Manufacturing (ExM) Technical Operation
organization is seeking a highly motivated individual for a this support
position. ExM Tech Ops is accountable for technology transfers and commercial
production of sterile drug product at our External Partners (EPs). This person
will have the opportunity to participate in all these areas. This may include
supporting the execution of technology transfers, providing manufacturing
process support to resolve commercial production issues, and to provide support
for process and capacity optimization.RequirementsResponsibilities include:Work with External Partners to achieve business goals and
to establish a common culture that benefits our company, External Partners, and
patients.Responsible for technical activities for the commercial
manufacturing process at the External Partner, which includes authorship of
change control, management of process improvement projects, statistical
analysis of process performance, and investigation of atypical events.Responsible for technical transfer activities, as
applicable, through authorship and/or review of required GMP documentation
(Master Batch Records, change control, protocols, reports, qualifications,
etc.) and regulatory filings.Provide on-site coverage at External Partner in support
of Commercial and / or Technology Transfer Person-In-Plant Activities.Translate understanding of GMP requirements and current
regulations and develop standardized work to meet these requirements by
partnering with Operations, Quality, and External Partners.Ensure that External Partners are inspection ready for
all routine inspections and / or inspections related to new product
introductions or transfers, in concert with Operations, Quality, and
Regulatory.Responsible for participation in creating, sharing, and
adopting best practices and business process strategies. Education Minimum Requirement:Must have fill finish Pre-Filled Syringe experience for
this role (Minimum 3-5 years)Bachelor’s degree in Chemical/Biochemical Engineering,
Pharmaceutical Science, or Chemistry/Biology, or other related science or
engineering field. Required Experience and Skills:Minimum of 4 years post-bachelor's degree experience in a
GMP functional area or support of a GMP functional area, such as Operations,
Technical Operations, Technology, Engineering, and/or MaintenanceTravel will be a requirement of this position at
approximately 25-50%Strong communication and teamwork skills Preferred Experience and Skills: Experience in Fill Finish activities – (Vial / Syringe finish,
Sterilization, cleaning aseptic manufacturing, etc.)Demonstrated ability to independently manage
projects/work to schedule/deadlinesStatistics experience (including Proactive Process
Analysis and Continuous Process Verification)Experience in deviation management and/or change control
and/or equipment support, and/or project management. #LI-EL1