Senior Validation Engineer
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| Job Type | Contractor |
| Area | Dublin |
| Sector | EngineeringQuality |
| Start Date | |
| Advertiser | Ashling Guthrie |
| Job Ref | 2866 |
| Job Views | 700 |
- Description
- Team Horizon is seeking a Senior Validation Engineer for our Clients vial and syringe fill finish manufacturing facility based in Dublin. This is an exciting role, where you will be responsible for delivering on the commissioning, qualification, and validation (CQV) program as well as for planning and executing the sterilization, decontamination, aeration and aseptic processing simulations. This position supports Operations and Quality Systems for Drug Product Manufacturing.
Why you should apply:
There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
What you will be doing:
Provide expert technical validation support to meet site objectives, comprising of the full validation lifecycles 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 company 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 requalification program in line with projects and site validation masterplans.
Collate and report on relevant validation data and metrics.
Assist in the development and improvements of the equipment validation and sterilisation lifecycle process while ensuring continued compliance to all applicable regulations and company standards. In addition, provide input and guidance into multisite and local procedural requirements.
Coordinate projects and prioritize workload in line with site priorities.
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.
Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
Participate in regulatory inspections, regulatory filings and RTQs
Attend and contribute to staff meetings and attend appropriate training sessions, as required.
Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.
Perform validation activities using a paperless validation system and identifying opportunities for improvement
Any other duties as assigned
What you need to apply:
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
In depth experience in equipment qualification and the validation lifecycle 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, organized, 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.
