CQV Engineer - #1101665

Position: CQV Engineer

Job Description

We are currently expanding our team and are looking for a CQV Engineer for our project on site with our client.

You will be responsible for planning, writing, implementing and reviewing Validation protocols in place within highly regulated environments. Your expertise will lend a hand in tactical problem-solving, effective communication, and creating a progressive growth culture.

Key Responsibilities:

• Create, review and approve qualification protocols such as FAT, SAT, IQ, OQ, PQ of existing manufacturing process equipment, package units (e.g. Ultrafiltration Unit, Chromatography Columns, autoclave, FIT testers), commercial off the shelves (COTS) analytical instruments, freezers

• Collaborate cross-functionally with QA, QC, Manufacturing, and Engineering teams to develop and execute cleaning validation and qualification protocols.

• Perform Cleaning Validation Monitoring (CVM) activities for GMP systems and equipment.

• Manage and investigate deviations, exceptions, and CAPAs related to GMP-released systems and validation activities.

• Draft, review, and execute validation documentation using ValGenesis or equivalent paperless validation systems.

• Ensure timely closure of validation activities and documentation in compliance with cGMP and internal quality standards.

Requirements:

• Degree in Science or Engineering with 3 years of working experience in GMP environment

• Understanding of manufacturing engineering experience in a Pharmaceutical/ Biotechnological company

• Experience with digital validation platforms such as ValGenesis is preferred.

What’s in it for you?

• Exposure to the most renowned Pharmaceutical companies in the industry

• Annual leave benefits

• Full Medical coverage

• Training and Development allowance

If you are interested in applying for this position, please send an email to [email protected].