Join a Market Leader Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market. Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites. Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life. You will be responsible to: + Enables theefficient manufactureofpharmaceutical products, includinghighly potent compounds, in compliance with applicablecGMPandHSE regulationsand in accordance withbusiness requirements. Responsible for thedefinition, implementation and optimizationofmanufacturing processesand systems, aiming at full adherence topre-established scheduleswhile managinginternal resources(people & equipment) and fulfillingcustomer requirements. + Fulfilland rigorouslypromoteall applicableGood Manufacturing Practices (GMP)andHealth Safety and Environment (HSE)regulations and relevant legislation by adhering toHovione´s policies and procedures(COPs, HBR, SOPs and others) andindustry standardswhile conducting all activities. + Plan and design manufacturing processesthat ensure the production ofintermediatesandfinal productsaccording to theproject plan(reliably, right first time, on time and within budget) and in compliance withcGMP,HSE regulationsandinternal policies and procedures. + Responsible for theaccurately and timely preparation and reviewofmanufacturing process documentation, including but not limited tobatch production records,campaign reports,change controls,operating manuals/procedures,mass balance sheets,bill of materials,cost proposals,validation plansandvalidation reports, and otherGMP-related documentationfor all processes run in operations. + Execute and ensure, with autonomy,risk assessmentsfor assigned activities and projects are carried out in compliance with established operating procedures and policies, assuring that all identifiedhazardsare addressed prior to performing any operational activities. + Report,investigateanddocumentanyabnormal observations, potentialrisks,discrepancies,deviationsandnon-conformancesin accordance withHovione internal procedures. + Timelydevise and implementeffective and efficientcorrective actions / preventive actions (CAPAs), as appropriate. + Participate in all necessarytrainingas defined in thetraining plan. + Report abnormal situationsat the installations, as soon as these are detected so thatcorrective maintenanceis triggered in due time. + Identify the necessarycorrective and preventive actionsto keep, in a proactive manner, the installation ingood conditions. + Act as thelead process engineerin multiple projects with limited support and liaises directly withcustomer project teams. + Updates theLine Managerand theteam memberson relevant occurrences and trends that may have a significant impact onArea KPIs. + Providetraining on manufacturing processes,production systemsandproceduresto operational team members. + Participate, as required, in theinduction of new colleaguesensuring they are appropriately trained in accordance with established training plans. + Drivehigh standardsin the production area (e.g. good hygiene, housekeeping and equipment maintenance practices), and act as an advocate forsafe operatingandhigh quality performance. + Supportinternal stakeholders, including but not limited to, generation of3P’sand answering queries oncostandcycle timeassociated with assigned processes (where applicable). + Assist withaudits and investigations. + Support the generation / reporting ofKPIsfor the team and follow allannual performance review requirements, including completion of theself-assessment. + Contribute to thedesign of new facilitiesor to themodification of existing ones. + Engage in asupportive work environmentthat allows foropen collaborationbetween team members to sharetechnical knowledge. + Develop and accumulate strongengineering expertise, sharing knowledge ofstate-of-the-art technologiesandmethodologieswithin the area. + Initiate and preparetech-transfersandprocess improvement projectsfor established and new processes utilizingbest available technology,practicesandtools. + Contribute to theincrease of productivityby reviewing, proposing, planning and implementing the introduction ofnew technologies,methodsandpracticesthat have the opportunity tooptimize the manufacturing processes. + Responsible for creating and reviewingcost proposalsandproject planswhen implementingoptimization projects. + Undertake anyadditional taskscommensurate with the role as and when required. + Carry out assigned tasks and duties in asafe manner, in accordance with instructions, and to comply withenvironmental, health & safety rules/procedures,regulationsandcodes of practice. We are looking to recruit a Candidate: + Degree in a field of Science or Engineering (with preference in Chemical Engineering) + Experience working within the pharmaceutical industry in Pharmaceutical Fine Chemistry and/or Particle Engineering and/or Drug Product (areas of development, scale-up and production) (mandatory) + Training and experience in GMP and HSE practices (desired) + Experience in equipment and technology design + Experience in technical manufacturing support + Experience of technical transfer and capital project support + Experience of multiple projects and products from early stage development to commercial scale + Strong interpersonal skills to enable effective interactions with stakeholders (written and verbal) + Competent (written and verbal) English + Computer literate with good working knowledge of the MS Office package and SAP + Intermediate knowledge in organic chemistry and/or particle engineering technologies + Intermediate knowledge in scale-up of chemical engineering operations and/or drug product + Must have the knowledge, experience and skills to conduct their tasks in accordance with the rules and procedures set down. Hovione is a proud Equal Opportunity Employer Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity. Notice to Agencies and Search Firms RepresentativesHovione does not accept unsolicited résumes from agencies or search firms for this job posting. Any resumes submitted to Hovione by a third-party agency or search firm without a valid written and signed search agreement will become the sole property of Hovione. No fees will be paid if a candidate is hired for this position as a result of an unsolicited referral. Thank you for your understanding. (https://en-careers-hovione.icims.com/jobs/10925/process-engineer/job?mode=apply&apply=yes&in\_iframe=1&hashed=-1834418400) Hiring Request Post Information* : Posted Date2 months ago(2025/6/10 11:13) ID2025-10925 # of Openings1 Job LocationsIE-Cork Job FamilyPRODUCTION