CQV Engineer (Senior)

Job Description 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: CQV Engineer (Senior)   Overview: ·         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. Requirements Key Responsibilities:   ·         Coordinates and Supervises all C&Q activities on their assigned projects. ·         Generate C&Q planning documents detailing overall project strategy. ·         Develops the master list of project C&Q test documents and activities. ·         Generates all C&Q summary reports. ·         Ensures the C&Q schedule is developed and maintained. ·         Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report) ·         Manages Daily C&Q coordination meetings. ·         Responsible for Overall 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. #LI-EL1 Requirements Key Responsibilities: · Coordinates and Supervises all C&Q activities on their assigned projects. · Generate C&Q planning documents detailing overall project strategy. · Develops the master list of project C&Q test documents and activities. · Generates all C&Q summary reports. · Ensures the C&Q schedule is developed and maintained. · Generation of all C&Q test documents (C&Q Plan/Set to Works/FAT/SAT/IV/FT/C&Q Summary Report) · Manages Daily C&Q coordination meetings. · Responsible for Overall 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.