Job Description

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 cGMPs 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.

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