Senior CQV Engineer
About this job
Our client based in Melbourne is seeking an experienced Senior CQV Engineer to support pharmaceutical, biotechnology and life sciences projects.
The role will involve commissioning, qualification and validation of facilities, utilities, equipment and systems within regulated GMP environments.
Key Responsibilities
Support commissioning, qualification and validation activities across project sites
Develop, review and execute CQV documentation including DQ, FAT, SAT, IQ, OQ and PQ
Review equipment and systems against approved specifications and user requirements
Participate in design reviews, risk assessments and qualification planning
Support investigations, deviations, CAPA and change control activities
Work closely with engineering, quality, manufacturing, vendors and project teams
Ensure documentation and project activities meet applicable GMP and regulatory requirements
Provide technical input and support throughout the project lifecycle
Skills and Experience
Degree in Engineering, Life Sciences, Pharmacy or a related technical discipline
Strong experience in CQV within pharmaceutical, biotechnology or another regulated industry
Experience with facilities, utilities, equipment and/or manufacturing systems
Knowledge of GMP and relevant regulatory requirements
Experience preparing and executing qualification and validation documentation
Strong technical writing, problem-solving and stakeholder management skills
Ability to manage multiple priorities and work effectively within multidisciplinary teams
Previous experience in senior CQV, validation or commissioning roles within regulated life sciences environments will be highly regarded.
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