Validation Engineer

About PSC Biotech

Who we are

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 points which include 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 to 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 through 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 regard to the quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are being met.

Key Responsibilities:

• Review of P&IDs during commissioning phase
• Generation of Change control and System Impact Assessment (Kneat)
• Review vendor documents for completeness
• Provide SAT support
• Validation document generation and protocol for equipment, including, but not limited to, process equipment and utility systems, both paper or using e-validation systems (Kneat)
• Execution of IQ and review/support for OQ.
• Closure of Change Control implementation tasks
• Work independently with the project manager, vendors, and contractors
• Provide Quality service adhering to SOP requirements
• Give necessary support for the timely completion of projects
• Be present on-site to provide full-time support.
• Computerized systems in particular to Agilent LCMS and GCMS
• Temperature Mapping
• Cleanroom Qualification