Senior Process Engineer
Senior Process Engineer
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Job Description
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 cloudbased 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 likeminded 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 diversecultural work setting.
Employee Value Proposition
Employees are the heartbeat of PSC Biotech we provide unparalleled empowering career development though Learning & Development inhouse 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 jobholder 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 commissioning
Packages may include Product Vessels Single Use Mixers Single Use UFDF skids & CIP/SIP skids.
Department:Technology Center Global Engineering Solutions (GES)
Requirements
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 crossfunctional 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 / startup / testing of process systems through OQ completion. Interface with crossfunctional team to ensure systems postOQ (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 jobholder will also undertake Project Engineering duties including:
- preparation of project related deliverables such as schedules work plans equipment cost tracking
- coordination 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/bioprocessing
- Minimum of 8 years post academic process engineering experience in relevant biopharmaceutical processing design construction & startup 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.
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/bioprocessing Minimum of 8 years post academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
Education
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/bioprocessing Minimum of 8 years post academic process engineering experience in relevant biopharmaceutical processing design, construction & start-up environment.
Employment Type
Full Time
