About PSC Biotech Who are we?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 PropositionEmployees 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 specification:We are looking for 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
on-going 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 principlesParticipate in the equipment qualification process IQ/OQ
through to PQ, including drafting of associated operational SOP’sLead 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. Provides frontline technical EHS support & coaching
to the operational team and be first point of contact for safety related
concerns (e.g. actions/Management Of Change/Permits/Risk assessments). Protocol/report authoring/execution/oversight/approval as
appropriate 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 process’s. Author/approve Change controls and MIDAS documents as
appropriateProvides frontline technical EHS support.Troubleshoot and optimize Vaccines Processing Unit
Operations (Cleaning, Sterilisation, Upstream, Lyophilisation, 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, maximise 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 #LI-EL1