CQV Engineer

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 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:

The Validation Engineer is responsible for the planning and execution of the qualification activities associated with all facility, utilities, equipment and instruments and process, cleaning and shipping validations in compliance with all relevant cGMP regulations, company policies and procedures.

Requirements

Role Functions:

• Execute qualification and validation activities for life cycle approach following validation plans and complying with cGMP and company procedures as part of the design, build and qualification, including ongoing operations to maintain the validated state.
• Author, review, execution and approval of testing protocols and reports. Responsible for project delivery, participate on project teams, vendor enquires and the troubleshooting and monitoring of process systems.
• Perform all duties in accordance with GMP requirements, SOPs and controlled documents.
• Will be flexible to take on additional tasks and responsibilities as requested. Will act as a role model for the Validation function and also the wider organization in adherence to thecorporate core values.
  
  

Experience, Knowledge & Skills:

• A minimum of 3 - 5 years’ experience working in a pharmaceutical or similar GMP environment as part of a validation, MSAT or engineering function.
• Experienced in the execution of commissioning and qualification/validation of facilities, utilities, equipment and instruments (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers).
• Experienced in the maintenance of the validated state, requalification/revalidation (CTUs, Cleanrooms, Clean Equipment etc.).
• Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations and equipment in a biologics processing environment.
• Experience of equipment vendor package ownership and system design coordination.
  
  

Qualifications & Education:

• A bachelor’s degree qualification in an engineering or science discipline.