Clean Utilities Commissioning and Qualification EngineerIndustry: Pharma/Biotech/Clinical ResearchWork Experience: 5+ yearsCity: DublinState/Province: DublinCountry: IrelandJob DescriptionAbout 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.
Employee Value Proposition Employees are the "heartbeat" of PSC Biotech. We provide unparalleled empowering career development through Learning & Development, in-house training, and mentorship to facilitate career progression. We believe in creating high-performing teams that can exceed our client's expectations regarding quality of all scalable and business unit deliverables, staying under budget, and ensuring timelines for our deliverables are met.
Description: Owns projects and equipment, responsible for document drafting and protocol execution.Overview: Clean Utilities Commissioning and Qualification (C&Q) engineer for various capital projects. Ensure the C&Q activities associated with various capital projects are completed safely, as per schedule, and in compliance with GMP and Quality Requirements.RequirementsKey Responsibilities: Commissioning & Qualification of Clean Utility Systems and execution of qualification documentation.Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report).Provide technical assistance during investigations and system design.Coordinates and supervises all C&Q activities on their systems.Ensures the C&Q schedule is maintained.Manages daily C&Q coordination meetings.Responsible for tracking and reporting of C&Q status and risks/issues.Ensures startup of equipment/utilities is completed in a safe and coordinated manner.Assist in the development of User Requirement Specifications (URS's) and Quality.Risk Assessment for Equipment and Automated Systems (QRAES).Education / Experience: 6+ years experience in Engineering or Commissioning and Qualification Management.Technical qualification at third level or equivalent in Engineering.Extensive knowledge and demonstrated experience managing Commissioning and Qualification for Pharmaceutical / Biotechnology projects preferred.Knowledge of safety, GMP, and environmental regulatory requirements.Demonstrated strong communication and leadership skills.Demonstrated ability to collaborate with senior stakeholders to achieve optimal outcomes.Strong understanding of a risk-based approach to commissioning and qualification within the biotechnology industry.Familiarity with paperless validation systems.
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