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 clients 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: Maintenance Senior technician Role Description: Responsible for maintaining and troubleshooting process devices, instrumentation and controls in support of vaccine manufacturing. Ensure that objectives are effectively achieved, requirements to ensure compliance, safety, and reliable supply to our customers. The Maintenance Technician will collaborate across functions, supporting, the project sub-teams maintenance requirements. Together, this dynamic group will meet the required project schedule milestones, in accordance with the applicable *** standards for Quality and EHS compliance. Requirements Role Functions: Provide effective technical support to Production in all aspects of machine and equipment maintenance, installation and modification; perform detailed maintenance, calibrations, PMs and troubleshooting. Required to operate and clean the process equipment as necessary. Collaborate and work cross functionally to develop and deliver on all aspects of the project through URS, FAT, SAT, IC, OC, IQ, OQ, PPQ and commercialization to meet schedule milestones Develop and setup the CMMS, Pro-Cal and general maintenance systems to support the project timelines and milestones. Maintain process and production equipment, ensuring ongoing preventative maintenance, equipment troubleshooting and repairs to ensure continuous, reliable and repeatable operation of all equipment; drive Total Productive Maintenance. Ensure effective management and equipment shutdown scheduling, ensuring resources are available, thereby minimizing downtown. Support maintenance planning and preventative maintenance through completion of planned and emergency work orders, calibrations, PMs etc. Document maintenance work, including upgrades, made to existing equipment, including preventative maintenance performed and parts used, to ensure appropriate documentation and records of repair history. Operate and monitor production support equipment, using MES/DCS and PLC based systems, to ensure optimum equipment uptime and target outputs, whilst facilitating continuous process improvements using Lean Principles. Operate, troubleshoot and repair complex systems which may include CIP, Autoclaves, Glassware Washers, production vessels, HVAC, Isolators, compressed gasses, plant steam/condensate, bulk chemical distribution and wastewater treatment under minimal supervision in a highly regulated, cGMP environment. Interpret P&IDs, equipment/system layouts, wiring diagrams, and specifications in planning and performing maintenance and repairs. Support continuous improvement by leading and active participation in repairs, upgrades, preventative maintenance and system failure investigations and investigation reports, execution/development of change control, and contribution to Kaizen events as appropriate. Perform root cause analysis of system failures, substandard equipment performance, using standard tools and methods, to resolve machine and system issues e.g. FMEA, Fishbone diagrams, 5 whys etc.; implement subsequent corrective action through the change management system. Identify and supply information and technical data for securing spare parts and equipment asset entry into the CMMS; liaise directly with vendors on supply of parts, upgrades to systems etc as necessary. Assist in general facility up keep and provides responsive customer support with emphasis on customer satisfaction. Ensure effective participation in writing/revising/ rolling out accurate , SAP task lists, technical engineering reports, training documents and maintenance procedures for various IPT systems; ensure all work is carried out in line with same. Develop and setup the CMMS, Pro-Cal and general maintenance systems to support the project timelines and milestones. Required to comply with client Global Policies, Procedures and Guidelines, regulatory requirements and execute current Good manufacturing Practices (cGMP) in the performance of day-to-day activities and all applicable job functions. Operate the processes and equipment as required to support site priorities. Work collaboratively to drive a safe and compliant culture. May be required to perform other duties as assigned. Foster a culture of continuous improvement by deploying Six Sigma tools and support implementation of Model Area within operations from the start. May be required to perform other duties as assigned. Expected travel 10% Experience, Knowledge & SkillS: QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS: General: Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers Understand the specific responsibilities of all Carlow departments as they relate to ones own department, understanding the business processes ones department supports Customer service Vendor liaison Self-motivated Flexible approach Effective time management and multi-tasking skills Excellent attention to detail Trouble shooting skills. Goal/results orientated. Data analysis Training skills Technical: Troubleshooting and maintaining process instrumentation and equipment. Understanding of mechanical/electrical/Instrumentation / pneumatic processes. Sterile filling processes Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. Report, standards, policy writing skills required. Proficiency in Microsoft Office and job-related computer applications required. Lean Six Sigma Methodology experience desired. Leadership: Focus on Customers and Patients Collaborate Act with Candour and Courage Make Rapid, Disciplined Decisions Drive Results Build Talent Demonstrate Ethics and Integrity Training: Actively mentors team members to improve individual and team performance. Drives continuous improvement of overall team skill level through focused observation, feedback, and training. Identifies and facilitates the implementation of new job aids, error proofing and improvements to existing training programs. Responsible for the value stream training and cross training. Qualifications & Education: Certificate or equivalent required Time serviced Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required. Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting. #LI-AM1
Qualifications & Education:
• Certificate or equivalent required
• Time serviced Apprenticeship or equivalent Certificate/Diploma in an Engineering or related discipline is required.
• Would typically have prior related work experience; ideally in a manufacturing, preferably GMP setting.
4-5 years
Experience, Knowledge & SkillS: QUALIFICATIONS & EXPERIENCE - KNOWLEDGE AND SKILLS REQUIREMENTS: General: • Effective communication and interpersonal skills to interface effectively with all levels of colleagues in a team environment, and with external customers • Understand the specific responsibilities of all Carlow departments as they relate to one’s own department, understanding the business processes ones department supports • Customer service • Vendor liaison • Self-motivated • Flexible approach • Effective time management and multi-tasking skills • Excellent attention to detail • Trouble shooting skills. • Goal/results orientated. • Data analysis • Training skills Technical: • Troubleshooting and maintaining process instrumentation and equipment. • Understanding of mechanical/electrical/Instrumentation / pneumatic processes. • Sterile filling processes • Knowledge of regulatory/code requirements to Irish, European and International Codes, Standards and Practices. • Report, standards, policy writing skills required. • Proficiency in Microsoft Office and job-related computer applications required. • Lean Six Sigma Methodology experience desired. Leadership: • Focus on Customers and Patients • Collaborate • Act with Candour and Courage • Make Rapid, Disciplined Decisions • Drive Results • Build Talent • Demonstrate Ethics and Integrity Training: • Actively mentors team members to improve individual and team performance. • Drives continuous improvement of overall team skill level through focused observation, feedback, and training. • Identifies and facilitates the implementation of new job aids, error proofing and improvements to existing training programs. • Responsible for the value stream training and cross training.
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