Thermal Mapping Validation Engineer
Ellab is a leading international supplier of high quality, precision measuring equipment and software for data analysis is used for validation and documentation of thermal processes in life science and medical device industries. Ellab also supplies validation services that support development and manufacturing organizations throughout the lifecycle of a product. QualUs is part of the Ellab Group and located in Ireland.
Specializing in thermal validation, QualUs is a validation service company that serves the pharmaceutical, medical device and healthcare industries. We have excellent for a number of Validation Engineers to join their team on a minimum of a 12-month contract with the opportunity to progress.
This is the ideal role for a talented Validation Engineer with experience of a GMP environment. Experience of autoclave, equipment validation, instrument calibration and a track record or knowledge of using the E-Val Pro wired validation system (or equivalent datalogger is desirable but not essential as full training will be provided), looking to join a successful and growing company. For the right candidate, there may also be the opportunity to join our client on an extended basis.
As a Validation Engineer, you will be responsible for the Steam In Place (SIP) activities in Upstream and Downstream equipment and ensuring that all customer quality requirements are adhered to. You should have experience in coordinating and performing temperature mapping and validation of equipment such as autoclaves, fridges, freezers, incubators, stability cabinets as well as SIP systems. In addition, working in a sterile manufacturing environment, you will execute Steam In Place (SIP) cycle development and performance qualification studies on Upstream and/or Downstream process equipment including Bioreactors, Centrifuge, Process Skids and Vessels. You will produce validation protocols and qualification reports and ensure that good documentation practices are adhered to when generating reports. Full training will be provided to achieve this.
Your other duties will include:
- Calibrating thermocouples and performing post-study calibration verifications
- Ensuring that safety procedures are adhered to during sterilization studies
- Assisting with deviation and exception resolution
To be considered for this role:
- Experience of working with upstream and downstream systems or equivalent vessels/equipment is an advantage
- Be able to work on your own initiative and execute validation studies
- Be competent in the handling and placement of Biological Indicators is an advantage
- Have a third level qualification in a scientific, engineering, biological or quality discipline
- Experience in Lock-out Tag-out (LOTO) is desirable but not essential
- Experience in the ability to walk-down P&IDs is desirable
Analytical and focused, as a Validation Engineer, you must have strong interpersonal, communication and organizational skills with a meticulous attention to detail.
To apply for the role of a Validation Engineer, please contact Gerard Collins on as soon as possible – immediate starts available. In your cover email, please indicate:
- Preferred location
- Salary expectations
- Current notice period
Ellab is an international company with manufacturing, research and development facilities in Denmark. Our Validation Solutions are sold and supported through Ellab sales and service companies in 11 countries and by more than 40 distributors. With more than 71 years of experience, Ellab has around 370 dedicated employees worldwide. Ellab improves the quality of life by contributing to building confidence in the food, pharmaceutical and medical device industries by providing solutions for recording, monitoring and validating critical parameters of thermal processing procedures. In 2019 we joined forces with Hanwell Solutions Ltd. in UK in order to expand our product offering to cover industry leading wireless environmental monitoring systems. EQT (www.eqtgroup.com) has acquired the majority ownership in Ellab.