About PSC Biotech Who are we?PSC Biotech is a leading Biotech Consultancy firm foundedin 1996, 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 Careerto 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 ValuePropositionEmployees 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:New exciting opportunity now exists on our Carlow Sitefor a Process Engineer to join the Process Engineering Group on site and reportto the Technical Engineering ManagerOur new team member will serve as technical support fornew product introduction (NPI) and commercial manufacturing and willparticipate and/or lead cross functional or single function teams includingliaising with vendors or above site groups. You will typically have priorrelated work experience; ideally in manufacturing, preferably GMP Setting butwe will consider applicants from other working environments as long as theyhave technology transfer experienceKnowledge of process monitoring systems, automation systems(DeltaV), operational intelligence & data systems (Pi System) within a GMPmanufacturing environment would be beneficial and desirable but not a necessityfor this roleOur Engineers support internal and external manufacturingoperations remain operational, continuously improve and innovate. With ourextensive range of facilities and environments, our Engineers haveopportunities across many diverse areas including Biological, Chemical,Automation, Capital Projects, Maintenance, Safety, Process Development,Technical Services, Utilities and Validation.
RequirementsResponsibilities:Design/Author/Review/Approve/Executequalification/validation documentation and process development studies in linewith the standard approval processDesign/Author/Review/Approve/ExecuteExecution/development of change controlsContribution to Kaizen events as appropriateTechnical input into quality notification byauthoring/reviewing/approving investigationsExecution of equipment/qualification validation programs;including re -qualification and re -validationSupport continuous improvement through Lean Six SigmamethodologiesPerform root cause analysis of system failures,substandard performance, using standard tools and methods, to resolve machineand system issuesServe as technical engineering representative forinternal technical group discussions and represent technical Operations Carlowat global technical forumsDrive compliance of Global Policies, Procedures andGuidelines, regulatory requirements and execute current Good manufacturingPractices (cGMP) in the performance of day to day activities and all applicablejob functions, ensuring consideration of the impact on GMP and compliance anddecisions made. Accountable for compliance via documentation completion, riskassessments, closing out corrective action, participate in audits andinspections and proactively highlighting any issues around complianceWork collaboratively to drive a safe and compliantculture in CarlowMay be required to perform other duties as assignedSkills Required:Bachelor's Degree or higher preferred; ideally in aScience, Engineering or other Technical disciplineMin 3 years experience ideally in manufacturing,preferably GMP SettingDemonstratable experience of leading technical relatedprojectsEvidence of continuous professional development isdesirableKnowledge of process monitoring systems, automationsystems (DeltaV), operational intelligence & data systems (Pi System)within a GMP manufacturing environment would be beneficial and desirable butnot a necessityKnowledge 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 computerapplications requiredExcellent communication, presentation, and interpersonalskills, to interface effectively with all levels of colleagues and withexternal customers in a team orientated mannerHybrid role once successful completion of training,occasional shift support as required based on program needs