▷ Apply Now Senior Process Design Engineer

2 weeks ago

Dublin Pike, Ireland Pharmalliance Consulting Ltd. Full time

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

Requirements Education:
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 sizing
Strong understanding of process hydraulics, clean utility distribution, and automation sequencing logic
In-depth knowledge of regulatory guidelines such as EU GMP, FDA, and Annex 1
Skilled in AutoCAD, P&ID software, and process modelling tools
Skills:
Excellent cross-functional collaboration skills (working with automation, QA, validation, and production teams)
Strong analytical and problem-solving abilities
Effective technical communication and documentation skills
Experience in sterile facility design, biotech, or pharmaceutical manufacturing
Familiarity with GMP cleaning validation, contamination control, and commissioning processes (FAT, SAT, IQ, OQ, DQ)
Knowledge of ISPE Baseline Guides and ASME BPE standards
Must be legally eligible to work in Ireland.

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