Senior CQV Engineer

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

Job Type: Permanent position | Full time position

Job Description

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.