Industry Pharma/Biotech/Clinical Research
Work Experience 4-5 years
City Cork
State/Province Cork
Country Ireland
Job Description
About PSC Biotech
Who are we?
PSC Biotech is a leading Biotech Consultancy firm foundedin ****, headquartered in Pomona, California, USA, with Global operations inIreland, India, Singapore, Australia and the US, serving 350 clients in morethan 23 countries worldwide.
We provide cloud-based software solutions forQuality Management and Regulatory Inspections, pharmaceuticals contractmanufacturing professionals, and metrology services to our clients.
'Take your Career to a new Level'
PSC Biotech disrupts the conventional consultancy modelby aligning our EVP as one of the unique selling point which includes theopportunity to work with the most talented cohort of like-minded professionalsoperating in the Pharma/ Biotech Industry.
We offer a permanent contract ofemployment giving exposure of working in Top Pharmaceutical client sites in adiverse-cultural work setting.
Employee Value Proposition
Employees are the "heartbeat" of PSC Biotech, we provideunparalleled empowering career development though Learning & Developmentin-house training mentorship through constant guidance to facilitate careerprogression.
We believe in creating high performing teams that can exceed ourclient's expectations with regards to quality of all scalable and business unitdeliverables, staying under budget and ensuring timelines for our deliverablesare being met.
Overview:
Looking for senior Validation Engineer with team leadexperience reporting to the Commissioning Qualification and Validation Manager,day to day technical direction may be delegated to the Engineering ValidationTeam Lead as required, and is responsible for fulfilling validation activitiesin a GxP regulated environment,including implementation of laboratory systems, newmanufacturingequipment/processesandchangestoexisting equipment/processes.
Technical Operations group is responsible for creatingour drugs for use in clinical trials and for scaling production of those drugsfor the commercial market.
These individuals build and maintain cutting-edgemanufacturing processes and sites, provide quality assurance and qualitycontrol to ensure we meet regulatory standards, and procure the needed goodsand services to support manufacturing and coordinating the worldwide movementof our drugs to patients.
Requirements
Responsibilities:
In collaboration with plant support functions, assistwith planning, set up and implementation of Analytical InstrumentQualification, Facilities, Utilities, Equipment (FUE) Qualification and ProcessValidation programs.
Execute (protocol generation, execution, and finalpackage preparation) Validation activities related to the various Validationdisciplines e.g. FUE Qualification, CSV, New Product Introductions and ChangeControl.
Develop validation plans for specific systemimplementation projects.
Support the establishment of site validation policies,through development, generation and implementation of site validation masterplans, guideline documents and standard operating procedures.
Prepare and track to completion any assigned changerequests, deviations, quality events and associated CAPAs.
Develop and demonstrate an active approach to safety,industrial hygiene, environmental and regulatory compliance.
Assistwithpreparationofregulatoryfilings andparticipation during regulatory inspections/partner audits.
Maintain current knowledge of industry standards andregulatory requirements for products developed or manufactured, validationtechniques/approaches and systems utilized
Lead and represent validation in multi-departmentalmeetings and project teams.
Identifies and implements improvements to the EngineeringValidation systems.
Coordinatevalidationactivitiesinvolvingcross-functional, multi-departmentalteams including:Manufacturing,Process Sciences, Process Development, Quality Control, Quality Assurance,Regulatory Affairs, and others.
Drug Product-specific.
Drug Product experience is still apreference but we will look at other validation experience as well (e.g.Cleaning, Steam, Temperature Mapping).
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