Senior CQV Engineer - GMP Validation & Commissioning Leader

Job Capital Pty Ltd as Trustee for Job Capital Uni; Sydney; On-site; AUD 150,000 - 190,000; Full time

Job summary

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

You will develop CQV documentation, review equipment against specifications, participate in design reviews and risk assessments, and collaborate with engineering,

Qualifications

• Degree in Engineering, Life Sciences, Pharmacy or 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.

Responsibilities

• Support commissioning, qualification and validation 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

CQV

Validation

Regulatory compliance

Technical writing

Stakeholder management

Education

Engineering or Life Sciences degree

Job description

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

You will develop CQV documentation, review equipment against specifications, participate in design reviews and risk assessments, and collaborate with engineering,