Automation and IT Laboratory Equipment Qualification Engineer
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Job Description
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 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.
The AIT Labs Engineer will be responsible for delivery of Automation and IT scope on one or more lab projects in the portfolio of capital projects
Role Functions
Partner with local project teams to deliver Automation and IT aspects of Laboratory capital projects.
Develop and/or review System Development Life Cycle (SDLC) deliverables, compliant with MSD standards. Liaise with site AIT group to add input to site SOPs for lab systems.
AuthorReviewApproval of qualification documents for lab systems RS, CS, RTM etc.
Work with site teams on generation of requirement andor configuration specification and IOQ test protocols. Participate in execution of IOQ protocols for lab analytical instruments where required.
Provide input to the development of project schedules and document trackers.
Generate risk assessmentsvariance documentation and interface with site teams to close out same.
Work closely with the DDQ function to ensure compliance with Quality standards.
Interface with BioNX site teams for Enterprise system deliverables such as Empower, LIMS, MODA, LabX and Acronis etc.
Drive efficiencies in execution of projects to reduce costs and cycle times based on standards
Requirements
BSc in Engineering, Computer Science, and or other technical degree.
5 or more years of experience in project/automation/IT/CSV/IT and or a similar role with experience in laboratory analytical instrument qualification and system implementation.
Excellent facilitation, problem solving, collaboration and decision-making skills.
Ability to multitask and to handle tasks with competing priorities effectively and engage with stakeholders.
Demonstrated ability to troubleshoot, problem solve, analyse, and define business problems, develop business cases, and identify appropriate process and technological solutions are essential.
Proven facilitation, meeting/workshop management, project management and change management skills are essential.
Excellent written, oral communication skills, as well as strong presentation skills.
Experience with Laboratory systems such as Empower LIMS, MODA, LabX and Acronis.
BSc in Engineering, Computer Science, and or other technical degree. 5 or more years of experience in project/automation/IT/CSV/IT and or a similar role with experience in laboratory analytical instrument qualification and system implementation. Excellent facilitation, problem solving, collaboration and decision-making skills. Ability to multitask and to handle tasks with competing priorities effectively and engage with stakeholders. Demonstrated ability to troubleshoot, problem solve, analyse, and define business problems, develop business cases, and identify appropriate process and technological solutions are essential. Proven facilitation, meeting/workshop management, project management and change management skills are essential. Excellent written, oral communication skills, as well as strong presentation skills. Experience with Laboratory systems such as Empower LIMS, MODA, LabX and Acronis. Experience in automation equipment used in biopharma laboratories is an advantage LI-AM1
Employment Type
Full Time
Key Skills
