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

- RelationshipBuilding – 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.




- NegotiationSkills – Active listening, needs assessment, andpresents visions to build a consensus.
- AnalyticalSkills – Identifies, researches, and demonstrateslogical reasoning to communicate critical information.
- RationalPersuasion – 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.
- InterpersonalAwareness – 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’sDegree 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 cGMPs 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.

#J-18808-Ljbffr

📌 CQV Engineer II (Melbourne)
🏢 PSC Biotech
📍 Melbourne