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.Process Simulation Technical EngineerResponsible for providing process, technical, and
validation support to operations for Process Simulation development and
execution. Accountable for all studies
associated with the development of new components, products, processes systems
and facilities in relation to process simulations. Co-ordination, design and execution of
Process simulations as required.RequirementsRole Functions:Serve as technical support for manufacturing and new
product introduction.Design/Author/Review/Approve/Execute process simulations
studies in support of new product introduction and ongoing manufacturing
support.Provide technical input into quality notification by
authoring/reviewing/approving Process
Simulation related investigations.Design/Author/Review/Approve/Execute process simulation
qualification/validation documentation
and studies in line with the standard approval processPerform data analysis and make informed
decisions/recommendations around conclusions reached from data analysisSupport continuous improvement through Lean Six Sigma
methodologies.Leading and active participation in projects, system
failure investigations and investigation reports,Execution/development of change controls to support the
Process Simulation process Contribution to Kaizen events as appropriate.Perform root cause analysis of system failures,
substandard performance, using standard tools and methods, to resolve machine
and system issues e.g. FMEA, Fishbone diagrams, 5 why’s etc.;Implement subsequent corrective action through the change
management system. Serve as technical engineering representative for internal
technical group discussions and represent technical operations at global
technical forums in relation to process simulations.Participate and/or lead cross functional or single
function teams including liaising with vendors or above site groups.Drive compliance of 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, ensuring consideration of the impact on GMP and compliance and
decisions made. Accountable for compliance via documentation completion, risk
assessments, closing out corrective action, participate in audits and
inspections and proactively highlighting any issues around compliance.Work collaboratively to drive a safe and compliant
cultureMay be required to perform other duties as assigned. Core Competences: Technical:Knowledge of regulatory/code requirements to Irish,
European and International Codes, standards and PracticesReport, standards, policy writing skills requiredEquipment and process validationSterile filling processes and equipmentProficiency in Microsoft Office and job related computer
applications requiredLean Six Sigma Methodology experience desired Business:Excellent communication, presentation and interpersonal
skills, to interface effectively with all levels of colleagues and with
external customers in a team orientated mannerUnderstand the specific responsibilities of all departments
as they relate to ones own department, understanding the business processes
ones department supportsCustomer serviceVendor liaisonStrong influencing skillsSelf-motivatedFlexible approachEffective time management and multi-tasking skillsExcellent attention to detailTrouble shooting skillsData AnalysisGoal/results orientatedDemonstrable analytical and systematic problem solving
skillsTraining skillsStrong change management skillsEffective conflict resolution skillsNegotiation skillsBusiness acumenStrategy developmentProject management skillsRisk management skillsProgressive people management skillsAbility to effectively manage complex projects across
multiple disciplines Typical Minimum Experience:3 - 5 year’s operations experience in a sterile
manufacturing environment, preferably with Aseptic Process Simulations
execution.Demonstrated ability to coach and lead changeStrong Knowledge of Sterile Manufacturing Processes with
a focus on delivery and results within highly regulated controlled environmentBachelor’s Degree or higher preferred; ideally in a
Science, Engineering or other Technical Discipline