About PSC Biotech
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:
As a Senior Process Engineer, you will provide process engineering services in support of the design and commissioning & qualification of a significant expansion to an existing bulk vaccine processing facility. You will work with the Process Engineering Team as a client owner representative to deliver Project Objectives.
Key Responsibilities
* 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.
Requirements
* Bachelor's or Master's degree in Chemical or Biochemical Engineering or equivalent discipline.
* Minimum of 8 years of post-academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
* Demonstrated ability to lead / influence teams in a matrix team environment.
* Excellent communication/presentation/organizational skills.
* In-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 technologies.
* Knowledge of DCS/PLC process control platforms and industry SDLC methodology such as Delta V.