CQV Engineer II: Commissioning & Validation Lead

PSC Biotech; Melbourne; Sur place; AUD 120 000 - 160 000; Plein temps

Résumé du poste

PSC Biotech in Melbourne, Australia is seeking a CQV Engineer II to support commissioning, qualification, and validation of facilities and equipment. The role emphasizes maintaining design intent while enabling steady growth and development within the PSC mission.

The candidate will author controlled CQV documents, coordinate risk analyses, and collaborate across departments. Travel may be required as projects demand, with a focus on ensuring cGMP/Data Integrity compliance.

Qualifications

• CQV execution including commissioning, qualification and validation activities.
• Experience writing, reviewing GMP/GDP documents and technical specifications.
• Ability to develop SOPs, final reports and validation & quality policies.

Responsabilités

• To work alongside client teams in commissioning and qualification activities aligned with project objectives.
• Support to commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
• Initiate, author, revise, review, and complete controlled documents for CQV projects.
• Write and review GMP and GDP documents and technical specifications.
• Collaborate with multiple departments on project activities and deliverables.
• Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, PQ.
• Support development SOPs and review final reports.
• Contact and work with contractors and vendors on assigned projects.
• Mentor and provide consultation to the client and local team.
• Responsible for managing project activities and timelines.

Connaissances

CQV execution

Documentation writing

Analytical thinking

Communication skills

Formation

Bachelor's Degree in Engineering or Life Science

Description du poste

PSC Biotech in Melbourne, Australia is seeking a CQV Engineer II to support commissioning, qualification, and validation of facilities and equipment. The role emphasizes maintaining design intent while enabling steady growth and development within the PSC mission.

The candidate will author controlled CQV documents, coordinate risk analyses, and collaborate across departments. Travel may be required as projects demand, with a focus on ensuring cGMP/Data Integrity compliance.