CQV Engineer II in Melbourne

• Melbourne, Australia | Posted on 09/16/2026
• The

CQV Engineer II isresponsible for supporting and ensuring systems, facilities, and equipment meetthe design requirements to be put in place for a facility.

The incumbent isalso responsible and accountable for the execution of the PSC mission, “tomaintain the integrity and professionalism of our products and services whileenabling steady growth and development.”

• D U T I E S A N D R Es P O NSIBI L ITIE S
• Towork alongside the client team's in in commissioning and qualificationactivities that align with the project objectives
• Support to commission, qualify, and validate facilities, utilities, and/or equipment in assigned projects.
• Initiates, authors, revises, reviews, and completescontrolled documents for CQV projects.
• Writes and reviews GMP and GDP documents andtechnical specifications.
• Collaborate with multiple departments onassigned project activities and deliverables.
• Initiate and coordinate risk analyses, designreviews, execute FAT/SAT, IQ, OQ, and PQ.
• Supports development SOPs and review final reports.
• Contact and work with contractors and vendorson assigned projects.
• Mentoring and providing consultation to theclient and local team.
• Responsible for managing project activitiesand timelines.
• Provided status reports of projects to the PSCProject Manager.
• Ability to travel as needed.
• Additionalduties and responsibilities may be assigned from time-to-time.
• DE M O N S TR A T E D C O M P E T E N CI ES
• Relationship Building
• Works with and across formal and informalprofessional and social networks to build long-term partnerships andconnections in the life science industry.
• CQV Technical Execution

–Independently executes and delivers commissioning, qualification, andvalidation activities across assigned systems and projects.

• Negotiation Skills
• Active listening, needs assessment, andpresents visions to build a consensus.
• Analytical Skills
• Identifies, researches, and demonstrateslogical reasoning to communicate critical information.
• Rational Persuasion
• Presents key factors, influencing factors, and strategic goals to assist stakeholders in identifying solutions.
• Collaboration & Mentoring
• Supportsclients and junior engineers through technical guidance, effectivecommunication, and knowledge sharing.
• Interpersonal Awareness
• Ability to be aware of how actions, ideas, and communication can/does affect people and their outcomes.
• Agility
• Meets objectives by responding to competing and changing priorities andmultiple tasks under inflexible timelines.

Requirements

R E QU I R E D E D UC A TI O NA N DW O RK E X P E R I E N C E

• Bachelor’s Degree in Engineering or Life Science.
• 5-7years of applicable work experience i n the biomedical and pharmaceuticals industry.
• Min 3 years of expertise in CQV
• Proficientin authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Proficientin developing SOPS, final reports and validation & quality policies.
• Understandingof developing, executing and maintaining CQV procedures and policies.
• Hasgood understanding and complies to c GMPs and Data Integrity guidelines.
• Demonstratedstrategic thinking and implementation skills; proven analytical skills withability to translate. data to actionable plans; demonstrated ability to developand implement marketing and product/service. strategies by converting them intotactical marketing plans; execute and deliver results.
• Excellentpresentation and communication skills, written and oral, for a variety ofaudiences.
• Highlyorganized in planning and time management, with the ability to multi-task.
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