CQV Engineer

PSC Biotech - Australia; City of Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

PSC Biotech - Australia is seeking a CQV Engineer II to support commissioning, qualification, and validation across facilities and equipment. You will author and review CQV documents, SOPs, and final reports while collaborating with cross-functional teams to meet project objectives.

You will mentor colleagues, manage timelines and provide project status updates to the PSC Project Manager; travel may be required to client sites and vendors.

Qualifications

• Bachelor’s degree in engineering or life science required.
• 5–7 years of biomedical/pharma industry experience.
• At least 3 years CQV expertise and document execution (DQ, FAT, SAT, IQ, OQ, PQ, PV).
• Experience developing SOPs, final reports, and validation/quality policies.
• Understanding CQV procedures and data integrity guidelines.

Responsibilities

• Support commissioning and qualification activities aligned with project objectives.
• Author, revise, review controlled documents for CQV projects.
• Write GMP and GDP documents and technical specifications.
• Collaborate with multiple departments on project activities and deliverables.
• Coordinate risk analyses, FAT/SAT, IQ, OQ, PQ and PV activities.
• Mentor clients and local teams; manage project activities and timelines.
• Provide status reports to PSC Project Manager; travel as needed.

Skills

Relationship Building

CQV Technical Execution

Negotiation Skills

Analytical Skills

Rational Persuasion

Collaboration & Mentoring

Interpersonal Awareness

Agility

Education

Bachelor’s Degree in Engineering or Life Science

Job description

The CQV Engineer II is responsible for supporting and ensuring systems, facilities, and equipment meet the design requirements to be put in place for a facility. The incumbent is also responsible and accountable for the execution of the PSC mission, “to maintain the integrity and professionalism of our products and services while enabling steady growth and development.”

DUTIES AND RESPONSIBILITIES:

• To work alongside the client team's in in commissioning and qualification activities 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 completes controlled documents for CQV projects.
• Writes and reviews GMP and GDP documents and technical specifications.
• Collaborate with multiple departments on assigned project activities and deliverables.
• Initiate and coordinate risk analyses, design reviews, execute FAT/SAT, IQ, OQ, and PQ.
• Supports development SOPs and review final reports.
• Contact and work with contractors and vendors on assigned projects.
• Mentoring and providing consultation to the client and local team.
• Responsible for managing project activities and timelines.
• Provided status reports of projects to the PSC Project Manager.
• Ability to travel as needed.
• Additional duties and responsibilities may be assigned from time-to-time.

DEMONSTRATED COMPETENCIES:

• Relationship Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry.
• CQV Technical Execution – Independently executes and delivers commissioning, qualification, and validation activities across assigned systems and projects.
• Negotiation Skills – Active listening, needs assessment, and presents visions to build a consensus.
• Analytical Skills – Identifies, researches, and demonstrates logical reasoning to communicate critical information.
• Rational Persuasion – Presents key factors, influencing factors, and strategic goals to assist stakeholders in identifying solutions.
• Collaboration & Mentoring – Supports clients and junior engineers through technical guidance, effective communication, 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 and multiple tasks under inflexible timelines.

REQUIRED EDUCATION AND WORK EXPERIENCE:

• Bachelor’s Degree in Engineering or Life Science.
• 5-7 years of applicable work experience in the biomedical and pharmaceuticals industry.
• Min 3 years of expertise in CQV
• Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Proficient in developing SOPS, final reports and validation & quality policies.
• Understanding of developing, executing and maintaining CQV procedures and policies.
• Has good understanding and complies to cGMPs and Data Integrity guidelines.
• Demonstrated strategic thinking and implementation skills; proven analytical skills with ability to translate. data to actionable plans; demonstrated ability to develop and implement marketing and product/service. strategies by converting them into tactical marketing plans; execute and deliver results.
• Excellent presentation and communication skills, written and oral, for a variety of audiences.
• Highly organized in planning and time management, with the ability to multi-task.