Senior Validation Engineer

Title: Senior Validation Engineer

Contract Length: 12 Months

Pay rate: €60 - €64/hour

Work Schedule: Monday - Friday, 37.5H/W

Location: Dun Laoghaire, Dublin, Ireland

Role Overview:

Our client is looking for a Senior Validation Engineer to join their Validation department that conducts validation activities across equipment, utility, facility, cleaning, sterilisation and transport to support the Operations and Quality Systems of Drug Product Manufacturing. The successful candidate will be responsible for delivering on the commissioning, qualification, and validation (CQV) program at our client's fill/finish facility. 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, and the site's standards.
• 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.
• Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. cross functional investigation teams, Validation and C&Q network and ISPE network discussions to influence industry best practices.

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+ years' 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

jkirlew@i-pharmconsulting.com