• Job TitleRef:VALENG6_1682007601 Senior Validation Engineer
Rate 58 - 62 EUR
Location
Dún Laoghaire, Dublin
2023-04-20
2023-05-18
TypeContract
SectorTech Ops & Engineering

i-Pharmhttps://www.i-pharmconsulting.com/
Title: Senior Validation Engineer
Contract Length: 12 Months
Pay rate: €58 - €62/hour
Work Schedule: Monday - Friday, 37.5H/W (HYBRID)
Location: South Dublin, Ireland Role Overview:
Our client is looking for a Senior Validation Engineer to be responsible for delivering on the commissioning, qualification, and validation (CQV) program. In addition, you will be responsible for planning and executing the sterilisation, decontamination, aeration and aseptic processing simulations.
Some of the key responsibilities for the Senior Validation Engineer will include:
• Provide expert technical validation support to meet site objectives, comprising of the full validation life-cycles process across a varied equipment portfolio.
• Development, review and approval of Validation Plans... QRAES, URS, IV/FTs, SATs, Cycle development and PQs etc. for process equipment in line with GMPs, regulatory requirements
• Liaise with engineering, commissioning and qualification personnel, and external vendors regarding equipment qualification and cycle development best practices ensuring quality by design principles are being followed.
• Manage and execute the equipment validation cycle development, performance qualifications and re-qualification program in line with projects and site validation masterplans.
• Assist in the development and improvements of the equipment validation and sterilisation life-cycle process while ensuring continued compliance to all applicable regulations
Basic Qualifications:
• Bachelor of Science/Engineering degree or equivalent.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills
• 5+ year's experience in a similar role

Preferred Experience:
• In depth experience in equipment qualification and the validation life-cycle process in line with ASTM E2500.
• In depth experience qualifying filling systems within the sterile manufacturing environment of drug product.
• Previous experience in regulatory inspections.
• Independent, self-motivated, proactive, organised, able to multi-task in project environments and skilled in communication and collaboration.
• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Does this sound like you? If so, please apply today!
Get in touch to discuss this role!
My number is 020 7 551 0727
[email protected]
Dún Laoghaire County Dublin Ireland

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