Senior CQV Engineer - Islandwide, SG

Roles & Responsibilities

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 :

What’s in it for you?

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.

Tell employers what skills you have

Excellent Communication Skills

Management Consulting

Manufacturing Engineering

Computer Validation

Ultrafiltration

Chromatography

GMP

Validation testing

Process Validation

Cleaning Validation

Writing

Terminology

Manufacturing

Validation Tool

Analytical Instruments

Autoclave