Senior Manufacturing Engineer

  • Dublin
  • Psc Biotech Ltd
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. Title: Senior Manufacturing Engineer Requirements ·         Position is expected to execute nonconformance, CAPA, SICAR, Change Control and metrics oversight responsibilities.   Act as the category owner for all quality records and procedures. ·         The Specialist processes, investigates and acts as first responders to deviations. Addresses and expedites product deviation under the companys quality management system procedures and ensures compliance with regulatory agencies. ·         Monitors, investigates deviations, and determines corrective and preventive actions to appropriate company authorities to modify existing manufacturing or packaging process based upon trend, deviation, and related analyses. ·         Maintains unified product defect investigation operating procedures. ·         Provides technical expertise to optimize deviations management, corrective and preventive actions effectiveness, and prevent reoccurring events. ·         Maintains and monitors systems to ensure that all deviations received are appropriately investigated and concluded per the companys quality standards and procedures. ·         Communicate with all levels of the organization, facilitate development of solutions to critical business issues, and effectively define objectives to enable effective metric generation and reporting. ·         May serve as the primary point of contact between Site Plant Quality and the corporate Supplier Quality Management team to ensure the quality of raw materials used at the sites. ·         May assist in the development of work force model criteria to support business initiatives for the department needs.     Basic Qualifications: ·         Doctorate degree and 2 years of Quality and/or Manufacturing experience OR Master’s degree and 6 years of Quality and/or Manufacturing experience. ·         Bachelor’s degree and 8 years of Quality and/or Manufacturing experience OR associate degree and 10 years of Quality and/or Manufacturing experience ·         High school diploma / GED and 12 years Quality and/or Manufacturing experience   Preferred Qualifications: ·         6+ years related work experience (manufacturing, process development, or quality assurance) in in Biotech or pharmaceutical industry with demonstrated experience in compliance, problem solving, advance root cause analysis, critical thinking, project management, and quality systems. ·         Understanding of quality management systems and quality control processes related to Raw Materials utilization in clinical and commercial operations. ·         Thorough working knowledge of EU and US cGMPs regulations ·         Demonstrated ability to work with minimal supervision, present data in an organized and logical manner, and communicate effectively. ·         Demonstrated ability to coordinate and lead cross-functional project teams and deliver on schedule. ·         Demonstrated ability to navigate through ambiguity and provide a structured problem-solving approach. ·         Able to defend processes, procedures, and decisions during regulatory inspections. ·         Organizational savvy and presence to build effective relationships across functions. ·         Excellent interpersonal relationship skills. ·         Excellent Technical Oral and written skills, ability to write/evaluate investigation responses to comply to regulatory requirements. ·         General understanding of Operational Excellence skills with emphasis on Root Cause Analysis ·         Proficient with MSWord; MS Excel; MS PowerPoint;   MS Visio;   MS Project, Track wise. ·         Demonstrated ability to deliver results through living the client values. ·         Negotiation skills when working with external suppliers and internal team members. ·         Ability to maintain remote working relationships with colleagues at other client sites. #LI-BR1