PCS 7 Validation Engineer Location: Redmond, US Job ID: ATR 17640 Job Description Job Title: PCS 7 Validation Engineer Job Location: Redmond, WA – Hybrid Eligibility/Clearance: Must be authorized to work in the US Job Description: We are looking for a highly skilled and detail-oriented PCS 7 Validation Engineer to join our Automation/Validation team. In this critical role, you will be responsible for developing, authoring, and maintaining the foundational documentation required to validate Siemens PCS 7 control systems in a regulated GxP environment. Your expertise will be essential in ensuring our automated processes are compliant with industry standards (e.g., FDA 21 CFR Part 11, EU Annex 11, GAMP 5) and are fit for their intended use. While the primary focus is on document authoring, this role may also provide direct support for the execution of validation activities on-site. Key Responsibilities: -Develop, write, and maintain standardized CSV templates and test protocols for Siemens PCS 7 systems -Collaborate with cross-functional stake holders across Automation, Manufacturing, Quality and Engineering to understand system functionality and define testing requirements. -Ensure all validation documentation aligns with GAMP 5, internal SOPs, and regulatory requirements. -Support the execution of validation protocols, which may include setting up test equipment, witnessing tests, documenting results, and troubleshooting minor issues. -Identify, document, and assist in the investigation of deviations and non-conformances encountered during testing. -Generate summary reports to formally document the outcome of validation activities. Required Qualifications and Skills: -Proven experience (3+ years) in a validation role within a GxP regulated industry (Pharma, Bio-Pharma, Medical Device, etc.). -Must have hands-on experience with Siemens PCS 7 architecture and components (OS, BATCH, Historian etc.). -Demonstrable experience in drafting and authoring validation documents (IQ/OQ/PQ protocols) specifically for process control systems. -Strong understanding of relevant regulatory standards: FDA 21 CFR Part 11, EU Annex 11, and GAMP 5 guidelines. -Excellent technical writing and communication skills, with a keen eye for detail and accuracy. -Ability to work independently and manage multiple priorities in a fast-paced project environment. Arena Technical Resources, LLC, (ATR) is an Equal Opportunity Employer (EOE) who will provide equal employment opportunity to employees and applicants for employment without regard to race, ethnicity, religion, color, sex, pregnancy, national origin, age, veteran status, ancestry, sexual orientation, gender identity or expression, marital status, family structure, genetic information, or mental or physical disability. First Name Required Last Name Required Email Address Required Phone Number CountryNoneAfghanistanÅland IslandsAlbaniaAlgeriaAmerican SamoaAndorraAngolaAnguillaAntarcticaAntigua and BarbudaArgentinaArmeniaArubaAustraliaAustriaAzerbaijanBahamasBahrainBangladeshBarbadosBelarusBelgiumBelizeBeninBermudaBhutanBoliviaBonaire, Sint Eustatius and SabaBosnia and HerzegovinaBotswanaBouvet IslandBrazilBritish Indian Ocean TerritoryBritish Virgin IslandsBruneiBulgariaBurkina FasoBurundiCabo VerdeCambodiaCameroonCanadaCayman IslandsCentral African RepublicChadChileChinaChristmas IslandCocos (Keeling) IslandsColombiaComorosCongoCongo-BrazzavilleCook IslandsCosta RicaCôte d'IvoireCroatiaCubaCuraçaoCyprusCzechiaDemocratic People's Republic of KoreaDenmarkDjiboutiDominicaDominican RepublicEcuadorEgyptEl SalvadorEquatorial GuineaEritreaEstoniaEthiopiaFalkland IslandsFaroe IslandsFederated States of MicronesiaFijiFinlandFranceFrench GuianaFrench PolynesiaFrench Southern TerritoriesGabonGambiaGeorgiaGermanyGhanaGibraltarGreeceGreenlandGrenadaGuadeloupeGuamGuatemalaGuernseyGuineaGuinea-BissauGuyanaHaitiHeard Island and McDonald IslandsHondurasHong KongHungaryIcelandIndiaIndonesiaIraqIrelandIslamic Republic of IranIsle of ManIsraelItalyJamaicaJapanJerseyJordanKazakhstanKenyaKiribatiKuwaitKyrgyzstanLao People's Democratic RepublicLatviaLebanonLesothoLiberiaLibyaLiechtensteinLithuaniaLuxembourgMacaoMacedoniaMadagascarMalawiMalaysiaMaldivesMaliMaltaMarshall IslandsMartiniqueMauritaniaMauritiusMayotteMexicoMonacoMongoliaMontenegroMontserratMoroccoMozambiqueMyanmarNamibiaNauruNepalNetherlandsNew CaledoniaNew ZealandNicaraguaNigerNigeriaNiueNorfolk IslandNorthern Mariana IslandsNorwayOmanPakistanPalauPanamaPapua New GuineaParaguayPeruPhilippinesPitcairnPolandPortugalPuerto RicoQatarRepublic of KoreaRepublic of MoldovaReunionRomaniaRussiaRwandaSaint BarthelemySaint Helena, Ascension and Tristan da CunhaSaint Kitts and NevisSaint LuciaSaint MartinSaint Pierre and MiquelonSaint Vincent and the GrenadinesSamoaSan MarinoSao Tome and PrincipeSaudi ArabiaSenegalSerbiaSeychellesSierra LeoneSingaporeSint Maarten (Dutch part)SlovakiaSloveniaSolomon IslandsSomaliaSouth AfricaSouth Georgia and the South Sandwich IslandsSouth SudanSpainSri LankaState of PalestineSudanSurinameSvalbard and Jan MayenSwazilandSwedenSwitzerlandSyriaTaiwanTajikistanThailandTimor-LesteTogoTokelauTongaTrinidad and TobagoTunisiaTurkeyTurkmenistanTurks and Caicos IslandsTuvaluU.S. Virgin IslandsUgandaUkraineUnited Arab EmiratesUnited KingdomUnited Republic of TanzaniaUnited StatesUnited States Minor Outlying IslandsUruguayUzbekistanVanuatuVaticanVenezuelaVietnamWallis and FutunaWestern SaharaYemenZambiaZimbabwe State/ProvinceNone City ZIP/Postal Code Resume Choose File... Required, maximum file size is 512KB, allowed file types are doc, docx, pdf, odf, and txt Message Success! Your application was successfully sent!