Industry Pharma/Biotech/Clinical Research Work Experience 4-5 years City Cork State/Province Cork Country Ireland Job 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.
'Take your Career to a new Level' PSC Biotech disrupts the conventional consultancy model by aligning our EVP as one of the unique selling points 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 to 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 through 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 Specification: We are looking for a Technical Specialist to join our team.
This is a leading facility for the development, testing and manufacturing of vaccines, exporting to over 90 countries across the world with a team of approximately 500 people.
The site has been a vibrant part of the local community for nearly 35 years and is now one of the region's largest employers.
Our manufacturing division is a team of dedicated, energetic individuals who are committed to being the most trusted supplier of pharmaceuticals and health products worldwide. Our facilities, along with our external contractors, suppliers, and partners, comprise an interdependent global manufacturing network that's committed to delivering a compliant, reliable supply to customers and patients on time, every time, across the globe.
The Technical Specialist will provide expert technical & engineering support within either the Vaccines IPT. This role will ensure ongoing optimization of the process to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the client Manufacturing Division Priorities of: Compliance, Supply, Strategy, and Profit Plan.
RequirementsRole Functions: Lead and participate in problem solving teams.
Ownership, effective planning & execution of continuous improvement projects to enhance and improve the process through lean manufacturing principles.
Participate in the equipment qualification process IQ/OQ through to PQ, including drafting of associated operational SOP's.
Lead and participate in problem solving teams across all areas of the IPT (e.g. reliability, Safety, Quality (e.g. CAPA/QNs etc).
Lead and close process-related deviations and reports.
Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. EHS metrics, Production Plan, OEE, compliance and team training.
Provide frontline technical EHS support & coaching to the operational team and be the first point of contact for safety-related concerns (e.g. actions/Management Of Change/Permits/Risk assessments).
Ensure highest Quality, Compliance and Safety standards.
Participate and comply with the client Manufacturing Division Quality Management Systems (QMS) requirements, including ownership, as relevant.
Provide ongoing coaching and support to cross-functional team members, to share process, engineering, and maintenance best practices.
Provide coaching and development to all technicians within the IPT.
Tactical Implementation & Support for reliability equipment initiatives.
Ensure supply of high-quality product through ensuring equipment availability; maximize team member performance through continuous process improvement initiatives.
Provide technical, process, and engineering expertise within a wide range of projects within the IPT, such as the introduction of new equipment and processes.
Author/approve Change controls and MIDAS documents as appropriate.
Provide frontline technical EHS support.
Troubleshoot and optimize Vaccines Processing Unit Operations (Cleaning, Sterilization, Upstream, Lyophilization, Downstream, Buffer Preparation, PSA, and Material Flow).
Ensure highest Quality, Compliance and Safety standards.
Participate and comply with the Quality Management Systems (QMS) requirements, including ownership, as relevant.
Tactical Implementation & Support for technical process and reliability Initiative.
Ensure supply of high-quality product through ensuring equipment availability, maximize team member performance through continuous process improvement initiatives.
Responsible for driving a culture of Reliability and Continuous Improvement through digitally enabled continuous improvement processes.
Education, Knowledge & Skills: Level 8 honours degree in a science, engineering or manufacturing discipline.
3-5 years experience in a highly regulated manufacturing environment in a technical or manufacturing support role.
Evidence of Continuous Professional Development.
Knowledge of and experience in applying Lean Six Sigma and Lean methodologies, with an understanding of regulatory and validation requirements.
Ability to interact with multiple stakeholders.
Demonstrated problem-solving capabilities.
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