Validation Testing Engineer [Solo Quedan 15h]...

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.

‘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.

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.

Cleaning Validation Executor

Taking Cleaning Validation samples alongside Upstream / Downstream processing.

Working closely with manufacturing to ensure the CIP / SIP and dirty holds are to the correct times and samples are taken.

Experience in Validation specifically cleaning validation.

Experience in assessment of cleaning issues during study runs.

Experience in Deviation / Change control writing,

Capable of managing a large program, so project management skills would be necessary.

An excellent understanding of how manufacturing / Cleaning Validation / Cleaning equipment works.

Experienced in coverage testing and clean-into-service.

Maintain and update Cleaning Validation Plan.

Schedule of cleaning activities with Manufacturing.

Ensure Training is maintained and current.

Execution of cleaning validation protocols.

Experience on writing and approving Deviations / GMP documents.

Technical writing experience in writing site reports.