Job Description

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Job Capital Pty Ltd as Trustee for Job Capital Uni – Millers Point NSW

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Job Type: Permanent position | Full time position

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Job Description

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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 n

Support commissioning, qualification and validation activities across project sites

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Develop, review and execute CQV documentation including DQ, FAT, SAT, IQ, OQ and PQ

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Review equipment and systems against approved specifications and user requirements

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Participate in design reviews, risk assessments and qualification planning

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Support investigations, deviations, CAPA and change control activities

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Work closely with engineering, quality, manufacturing, vendors and project teams

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Ensure documentation and project activities meet applicable GMP and regulatory requirements

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Provide technical input and support throughout the project lifecycle

Skills and Experience n

Degree in Engineering, Life Sciences, Pharmacy or a related technical discipline

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Strong experience in CQV within pharmaceutical, biotechnology or another regulated industry

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Experience with facilities, utilities, equipment and/or manufacturing systems

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Knowledge of GMP and relevant regulatory requirements

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Experience preparing and executing qualification and validation documentation

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Solid technical writing, problem-solving and stakeholder management skills

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Ability to manage multiple priorities and work effectively within multidisciplinary teams

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Previous experience in senior CQV, validation or commissioning roles within regulated life sciences environments will be highly regarded.

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📌 Senior CQV Engineer (New South Wales)
🏢 Job Capitalas Trustee for Job Capital Uni
📍 New South Wales