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 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 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.Role Description: Responsible for providing process, technical, and validation
support to operations for commercial manufacturing and 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
commercial & Process simulations studies as required.RequirementsRole Functions:(Functions include, but are not limited to, the following)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 commercial &
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 processContribution 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 processsimulations.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 culture
in Client site.May 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 Experience, Knowledge & Skills:Typical Minimum Experience:Experience in a Aseptic sterile manufacturing environment
preferredDemonstrated ability to coach and lead changeStrong Knowledge of Sterile Manufacturing Processes with a
focus on delivery and results within highly regulated controlled environment Qualifications & Education:Typical Minimum Education:Bachelor’s Degree or higher preferred; ideally in a Science,
Engineering or other Technical Discipline#LI-AM1