Validation Engineer

1 day ago

Cork, Cork, Ireland Arcadis DPS Full time
Validation Engineer The successful Validation Engineer will report to the Project Validation Lead and assist the team for project qualification.
A Degree qualified Engineer with B.
S.
in Engineering and 3+ years of experience or related equivalent work experience Must have experience with c GMPs and Good Engineering Practices.
Experience in executing multiple projects and participating on cross-functional project teams.
Duties and Responsibilities Perform Qualification and Validation of Manufacturing Equipment, QC equipment, and Supply chain equipment including FAT, SAT, Installation and Operational Qualifications, and performance qualifications (cleaning, temperature mapping, sterilization).
Perform Validation Maintenance program tasks to ensure GMP Manufacturing Equipment, Facilities, Utilities, Computer Systems, and Process remain in a validated and controlled state in accordance with original validation criteria to maintain product supply.
Perform manufacturing equipment design qualification and risk assessment to ensure that the equipment design is meeting manufacturer's specification and functional requirements.
Coordinate the scheduling of validation execution by collaborating with Manufacturing and Quality Control departments and analyze the test results against pre-determined acceptance criteria.
Collaborates with Manufacturing, Engineering, Process Support, Supply Chain, Quality to ensure a specific product meets current regulation and quality standards.
Prepare, maintain, and review Validation documentation such as CQV documentation for FAT, SAT, IQ, OQ, PQ.
Review equipment calibration specifications and any out of tolerance records to determine the extent of failure on the validation test.
Execute Quality System elements like Change Controls, Deviations and Investigations resulting from equipment and utilities qualification protocol execution.
Perform investigation on validation protocol discrepancies to identify the root causes of validation test or production problems.
Arcadis | DPS Group 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 | DPS Group is an Equal Opportunities Employer.
Recruitment Agencies: Please do not reply to this job advert.

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