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Senior Process Design Engineer - CIP & SIP Systems

Pharmalliance Consulting
Contract
On-site
Dublin, Leinster, Ireland

Position Overview:<\/span><\/b>
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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.<\/span>
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Key Responsibility: <\/span><\/b>
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  • Lead the design of CIP and SIP systems for sterile and non -sterile pharmaceutical processes<\/span>
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  • Perform pump sizing, hydraulic calculations, and process line sizing for liquid and utility distribution<\/span>
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  • Develop and specify CIP manifolds, valve matrices, mix -proof valve arrays, and spray device sizing<\/span>
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  • Design efficient CIP/SIP flow paths, optimizing for minimum dead legs and effective coverage<\/span>
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  • Write CIP process descriptions including sequences, detergent dosing, rinse validation, and drain cycles<\/span>
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  • Integrate automated valve control and sequencing logic for repeatable and validated CIP operations<\/span>
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  • Support design and layout of clean utility distribution systems, including steam -in -place routing and condensate removal<\/span>
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  • Ensure designs comply with regulatory standards (EU GMP, FDA, Annex 1) and operational efficiency<\/span>
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  • Generate and review key design documentation such as URS, PFDs, P&IDs, and equipment specifications<\/span>
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  • Support FAT, SAT, commissioning, and qualification (DQ, IQ, OQ) activities<\/span>
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  • Collaborate with automation, quality, production, and validation teams throughout design and implementation<\/span>
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    Requirements<\/h3>
    Education:<\/span><\/span><\/b><\/div>

    Bachelor’s degree in Chemical, Mechanical, or Process Engineering.<\/span>
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    Experience:<\/span><\/span><\/b><\/div>

    Minimum of 8 years’ experience in pharmaceutical engineering, with a strong focus on CIP and SIP systems within GMP manufacturing environments.<\/span>
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    Certifications (Desirable):<\/span><\/span><\/b><\/div>

    Additional training or certification in contamination control, process engineering, or automation platforms (e.g. Siemens, Rockwell) is a plus.<\/span>
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    Technical Expertise:<\/span><\/span><\/b><\/div>

    • Proficient in CIP/SIP system design including pump sizing, valve matrix configuration, and spray device sizing<\/span>
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    • Strong understanding of process hydraulics, clean utility distribution, and automation sequencing logic<\/span>
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    • In -depth knowledge of regulatory guidelines such as EU GMP, FDA, and Annex 1<\/span>
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    • Skilled in AutoCAD, P&ID software, and process modelling tools<\/span>
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      Skills:<\/span><\/span><\/b><\/div>

      • Excellent cross -functional collaboration skills (working with automation, QA, validation, and production teams)<\/span>
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      • Strong analytical and problem -solving abilities<\/span>
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      • Effective technical communication and documentation skills<\/span>
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        Desirable Attributes:<\/span><\/span><\/b><\/div>

        • Experience in sterile facility design, biotech, or pharmaceutical manufacturing<\/span>
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        • Familiarity with GMP cleaning validation, contamination control, and commissioning processes (FAT, SAT, IQ, OQ, DQ)<\/span>
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        • Knowledge of ISPE Baseline Guides and ASME BPE standards<\/span><\/span><\/p><\/li><\/ul>

          Work Eligibility: <\/span><\/span><\/div><\/h3>
          Must be legally eligible to work in Ireland.<\/span>
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          No sponsorship available.<\/span><\/span><\/b>
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