Senior Process Design Engineer

2 weeks ago

Dublin, Ireland Pharmalliance Consulting Ltd. Full time

Senior Process Design Engineer - CIP & SIP SystemsPharmalliance offers specialist support to pharmaceutical companies to maintain and increase quality compliance levels.We specialize in Contamination Control and have a suite of services to help you stay compliant no matter what your stage of development.Job DescriptionPosition Overview:The Senior Process Design Engineer will lead the design and implementation of Clean-in-Place (CIP) and Sterilise-in-Place (SIP) systems within GMP pharmaceutical manufacturing environments.This role involves managing the full lifecycle of process and utility design, including pump sizing, valve matrix configuration, automation sequencing, and regulatory compliance with standards such as EU GMP, FDA, and Annex 1.The successful candidate will collaborate with cross-functional teams to ensure efficient, validated cleaning and sterilisation processes, supporting facility design, upgrades, and commissioning activities.Key Responsibility:Lead the design of CIP and SIP systems for sterile and non-sterile pharmaceutical processesPerform pump sizing, hydraulic calculations, and process line sizing for liquid and utility distributionDevelop and specify CIP manifolds, valve matrices, mix-proof valve arrays, and spray device sizingDesign efficient CIP/SIP flow paths, optimizing for minimum dead legs and effective coverageWrite CIP process descriptions including sequences, detergent dosing, rinse validation, and drain cyclesIntegrate automated valve control and sequencing logic for repeatable and validated CIP operationsSupport design and layout of clean utility distribution systems, including steam-in-place routing and condensate removalEnsure designs comply with regulatory standards (EU GMP, FDA, Annex 1) and operational efficiencyGenerate and review key design documentation such as URS, PFDs, P&IDs, and equipment specificationsSupport FAT, SAT, commissioning, and qualification (DQ, IQ, OQ) activitiesCollaborate with automation, quality, production, and validation teams throughout design and implementationRequirementsEducation:Bachelor's degree in Chemical, Mechanical, or Process Engineering.Experience:Minimum of 8 years' experience in pharmaceutical engineering, with a strong focus on CIP and SIP systems within GMP manufacturing environments.Certifications (Desirable):Additional training or certification in contamination control, process engineering, or automation platforms (e.g. Siemens, Rockwell) is a plus.Technical Expertise:Proficient in CIP/SIP system design including pump sizing, valve matrix configuration, and spray device sizingStrong understanding of process hydraulics, clean utility distribution, and automation sequencing logicIn-depth knowledge of regulatory guidelines such as EU GMP, FDA, and Annex 1Skilled in AutoCAD, P&ID software, and process modelling toolsSkills:Excellent cross-functional collaboration skills (working with automation, QA, validation, and production teams)Strong analytical and problem-solving abilitiesEffective technical communication and documentation skillsExperience in sterile facility design, biotech, or pharmaceutical manufacturingFamiliarity with GMP cleaning validation, contamination control, and commissioning processes (FAT, SAT, IQ, OQ, DQ)Knowledge of ISPE Baseline Guides and ASME BPE standardsMust be legally eligible to work in Ireland.#J-*****-Ljbffr

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