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 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.

Job Title: Clean utilities Engineer

Job Description:

Reporting into Engineering Lead the Clean utilities Engineer will take ownership for the clean utilities (such as, but not limited to, Water for injection, clean steam, clean dry air, nitrogen). Responsible for the clean utilities’ equipment.

Requirements

Responsibilities:

• Responsible for delivery of schedule milestones throughout the project duration.
• Collaborate and work cross functionally to develop and deliver on all aspects of the project through SAT, IC, OC, IQ, OQ, PQ and commercialization to meet schedule milestones. The Clean Utility engineer role shall be responsible for execution of the Utility PQ's with the required support from site resources.
• Driving operational and technical excellence to deliver all components of a stable clean equipment portfolio supporting PPQ, facility start-up and commercial supply, supported by a flexible, collaborative, multi-skilled teamwork environment.
• Ownership of the clean utility Quality risk assessments and close out.
• Assist in the design and operationalisation of a successful clean utilities team that delivers right-first-time utilities to achieve production requirements.
• Resolve issues and escalate risks in a timely fashion to the relevant on-site stakeholders.
• Comply with the current Manufacturing Division, Quality and EHS Management System requirements, as relevant to the project and commercial operations.
• Ensure that the clean utilities team receive appropriate resources and programmes to develop technical and other skills, to complete their jobs whilst stimulating personal growth and development in line with role. Develop and maintain training programmes.
• Drive effective writing/revising/ rolling out of accurate operational procedures, training materials and maintenance procedures for various clean utility systems; ensure all work is subsequently carried out in line with same.
• Act as Owner rep for Turnover, SAT and OQ execution for all clean utilities.

What skills you will need:

• Degree qualification or equivalent (Science, Engineering, Technical).
• Experience in CQV execution.
• Knowledge and previous experience of Utility start up and qualification.
• Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices.