A new Validation Engineer role is now available based in Kerry. The successful Engineer will have experience in a GMP environment and hold a degree in Engineering or Science disciplines.
Main function of job: Review, approval, development and control of validation activities for all company projects, preparation of validation documentation and reports, and execution of validation protocols.
Validation Scheduling
* Evaluation of validation requirements including areas of: new equipment, change controls, new requirements
* Monitor status of projects and obtain updates where required.
* Provide support to ensure validation status reports are maintained through issuance of monthly reports and regular validation group meetings.
* Liaise with project PMs to ensure project schedule is adhered to.
Validation Standards
* Assessment of current practices to ensure compliance with cGMP requirements.
* Familiarisation with developments and innovations in validation requirements.
* Review/implementation of procedures, reports, results etc. for compliance.
* Review/implementation of CSV documentation.
* Responsible for coordination of Project SDLC Documentation.
Validation Preparation, Execution and Approvals
* Execution of validation protocols.
* Review and approval of all project validation protocols plant wide.
* Review and approval of project change controls.
* Preparation of validation documentation and reports as required.
* Provide input into the development of company validation standards.
* Present in a professional manner all enquiries raised by management and auditors.
* Tasks may vary depending on business and organisational needs.
Arcadis is a leading Project Management and Engineering Company delivering full-service engineering with a ‘client first’ mentality and personal touch across a range of market sectors: Project and Programme Management, Procurement, Design, Construction Management, Health & Safety Management, Commissioning, Qualification and Start-up. We have one goal: to deliver more than our clients expect first time, every time.
Arcadis is an Equal Opportunities Employer.
Seniority level
Mid‑Senior level
Employment type
Contract
Job function
Engineering and Production
Industries
Pharmaceutical Manufacturing and Biotechnology Research
County Kerry, Ireland €40,000.00-€65,000.00 (2 weeks ago)
#J-18808-Ljbffr