Senior Validation Engineer
Desired Skills: validation,HVAC,qualification
The role:
PE Global is currently recruiting for a Senior Validation Engineer on behalf of a leading biotech company in Dublin South. This is an initial 12 month contract role.
Overview:
The Validation department performs equipment, utility, facility, cleaning, and sterilization validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing.
Summary:
An exciting opportunity has opened in the validation team for a Senior Validation Engineer. In this role, you will be responsible for delivering on the qualification and validation program, which will include planning and execution of validation/requalification activities on critical equipment.This role will focus on HVAC qualification & validation in the production environments, including managing the routine re-qualification program of airflow visualisation, filter integrity, velocity & particle monitoring testing activities as well as testing in response to changes & expansion of the production environment.
This role may support (re)qualification of additional equipment on site as required (E.g. Isolators, E-Beams etc.)
Responsibilities:
- Provide technical validation support to meet site objectives, comprising the full validation lifecycle process.
- Develop, review, and approve validation plans, protocols, and discrepancy summary reports.
- Lead the execution of airflow visualization, filter integrity, velocity, and particle monitoring testing activities.
- Lead the execution of cycle development, performance qualifications, and requalification programs for VPHP isolators.
- Collate and report relevant validation data and metrics.
- Assist in the development and improvement of the validation lifecycle process while ensuring compliance with all applicable regulations and standards.
- Provide validation support for quality management system, including change control, deviation, and CAPA processes.
- Coordinate projects and prioritize workload in line with site priorities.
- Participate in multidisciplinary site and multisite teams, such as cross-functional investigation teams and change control.
- Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
- Attend and contribute to staff meetings and training sessions as required.
- Comply with the responsibilities outlined in the Site Safety Statement and champion safe working practices.
Education and Experience:
- Bachelor of Science/Engineering degree or equivalent.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- 5+ years’ experience in a similar role.
- Experience qualifying HVAC systems and/or executing VPHP qualifications.
- Familiarity with Quality and Document Management Systems, including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.
Interested candidates should submit an updated CV.
Please click the link below to apply, call Kellie on 0214297900 or alternatively send an up to date CV to kellie.hackett@peglobal.net
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***