About PSC BiotechWho 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 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.Role Description:As part of the IPT team, perform various production and
operations related tasks as part of an empowered team to aid in the manufacture
and reliable supply of product. Ensure that objectives are effectively achieved, consistent with client’s
requirements to ensure compliance, safety and reliable supply to our customers.RequirementsRole Functions:Operate and/or monitor production activities and support
equipment, using MES/DCS and PLC based systems, to ensure optimum equipment
uptime and target outputs. Equipment will include, yet is not limited to, parts
washers, autoclaves, portable tank CIP/SIP/storage panels, Vial Washer, Depyro
Tunnel, Debagger and filling machinesClean room cleaning, housekeeping and materials management
in all production areas while focusing on continuous process improvement using
Lean Principles.Manage equipment flow, including tracking soiled and clean
hold times, proper labeling and inventory management of clean and sterile
equipment using Kanbans and automated MES system to set QC status and expiry of
sterile equipment.Maintain process equipment, completing preventative
maintenance and equipment troubleshooting and repairs where qualified to
perform tasks.Participate effectively in writing/revising/ rolling out
accurate operational procedures, training materials for various IPT systems;
ensure all work is carried out in line with same. Support continuous
improvement by active participation in investigations and investigation
reports, execution/development of change control, and contribution to Kaizen
events and projects as appropriate. Perform root cause analysis, using standard
tools and methods, to resolve system issues e.g. FMEA, Fishbone diagrams, 5 why’s
etc.; implement subsequent corrective action through the change management
system.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.Work collaboratively to drive a safe and compliant culture.May be required to perform other duties as assigned. Experience, Knowledge & Skills:Core Competencies:Technical:Sterile filling processes and equipmentKnowledge of regulatory/code requirements to Irish, European
and International Codes, Standards and PracticesReport, standards, policy writing skills requiredProficiency in Microsoft Office and job related computer
applications required Business:Effective communication and interpersonal skills to
interface effectively with all levels ofcolleagues in a team environment, and with external
customersUnderstand the specific responsibilities of all departments
as they relate to onesown department, understanding the business processes one’s
department supportsCustomer serviceSelf-motivatedFlexible approachEffective time management and multi-tasking skillsExcellent attention to detailTrouble shooting skillsGoal/results orientatedTraining skills Leadership:Focus on Customers and PatientsCollaborateAct with Candor and CourageMake Rapid, Disciplined DecisionsDrive ResultsBuild TalentDemonstrate Ethics and Integrity Qualifications & Education:Typical Minimum Education:Leaving Certificate or equivalent requiredApprenticeship, Certificate or Diploma preferred, ideally in
a related disciplineTypical Minimum Experience for this Grade/Level:Would typically have prior related work experience; ideally
in a manufacturing, preferably GMP setting. #LI-XA1