CQV Engineer II: Validation & Commissioning Specialist

PSC Biotech® Corporation; City of Melbourne; On-site; AUD 110,000 - 150,000; Full time

Job summary

PSC Biotech Corporation seeks a CQV Engineer II to support and ensure systems, facilities, and equipment meet design requirements for new facilities. The role supports the PSC mission to maintain product integrity and enable growth.

Responsibilities include commissioning, qualification, validation activities, document authorship, and cross‑functional collaboration. Travel may be required to client sites as needed.

Qualifications

• Bachelor’s degree in engineering or life science.
• 5-7 years of biomedical/pharma experience.
• Min 3 years CQV experience.
• Proficient in authoring and executing DQ, FAT, IQ, OQ, PQ, PV documents.

Responsibilities

• Work with client teams on commissioning and qualification activities alignment.
• Support commissioning, qualification and validation of facilities, utilities, and equipment.
• Initiate, author, revise and complete CQV documents.
• Write and review GMP and GDP documents and technical specs.
• Collaborate with multiple departments on project activities and deliverables.
• Initiate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, PQ.

Skills

CQV

Documentation

GMP

Data Integrity

Analytical Skills

Negotiation Skills

Collaboration & Mentoring

Agility

Education

Bachelor's Degree in Engineering or Life Science

5-7 years of biomedical/pharma experience

Min 3 years CQV experience

Job description

PSC Biotech Corporation seeks a CQV Engineer II to support and ensure systems, facilities, and equipment meet design requirements for new facilities. The role supports the PSC mission to maintain product integrity and enable growth.

Responsibilities include commissioning, qualification, validation activities, document authorship, and cross‑functional collaboration. Travel may be required to client sites as needed.