Position: Senior CQV Engineer

Job Description

We are currently expanding our team and are looking for a Senior 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.
• Experience in writing and executing validation documents and SOPs for IQ, OQ, PQ for automated systems, and cleanrooms.
• Abide by all safety requirements and procedures pertaining to their role; serve as a positive model to others in this regard; re-enforce in meetings, perform periodic field observation and feedback as needed.
• Provide technical oversight to a Biopharmaceutical Process Equipment C&Q team to assure technical work quality, consistency, and alignment with the C&Q programme.
• Report on any proposals for deviating from the C&Q program during doc development and execution to ensure they are addressed and, if agreed on, documented in a timely manner.

Requirements:

• Degree in Science or Engineering with 6 years of working experience in GMP environment
• Understanding of manufacturing engineering experience in a Pharmaceutical/ Biotechnological company

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

Coalesce Management Consulting operates as an equal opportunity employer. No terminology in this advert is intended to discriminate on the grounds of age, race, religion, sexual orientation or any other factors with no bearing to employment skills and we confirm that we are happy to accept applications from persons of any background for this role.