CQV Engineer II

PSC Biotech Pte Ltd; City of Melbourne; On-site; AUD 104,000 - 127,000; Full time

Job summary

PSC Biotech Pte Ltd is seeking a CQV Engineer II to support and ensure systems, facilities, and equipment meet the design requirements for a facility. The role focuses on executing CQV activities and maintaining project documentation to uphold quality and regulatory standards.

The incumbent will author and review DQ, FAT, SAT, IQ, OQ, PQ and PV documents, collaborate with multiple departments, coordinate risk analyses, and support SOP development. Travel may be required based on project needs.

Qualifications

• Degree in Engineering or Life Science is required.
• 5-7 years of relevant work experience in biotechnology, pharmaceutical or medical device industries.
• Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.

Responsibilities

• Creates and maintains job plans, maintenance, and CQV functions.
• 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.
• Support the review and qualify equipment for commissioning, qualification, and validation activities.
• 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 final reports.
• Contact and work with contractors and vendors on assigned projects.
• Stay updated on industry trends and regulatory requirements, providing informed insights and ensuring compliance.

Skills

CQV

GMP knowledge

Regulatory understanding

Communication skills

Education

Degree in Engineering or Life Science

Job description

Job Type: Permanent position | Full time position

Job Description

POSITION SUMMARY: 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: Creates and maintains job plans, maintenance, and CQV functions. 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. Support the review and qualify equipment for commissioning, qualification, and validation activities. 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. Stay updated on industry trends and regulatory requirements, providing informed insights and ensuring compliance across the PSC Biotech organisation and client organisations. Ability to travel as needed.

Additional duties and responsibilities may be assigned from time-to-time.

DEMONSTRATED COMPETENCIES:

Building – Works with and across formal and informal professional and social networks to build long-term partnerships and connections in the life science industry.

Skills – Active listening, needs assessment, and presents visions to build a consensus. Skills – Identifies, researches, and demonstrates logical reasoning to communicate critical information. Persuasion– Presents key factors, influencing factors, and strategic goals to assist stakeholders in identifying solutions.

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:

Degree in Engineering or Life Science. 5 -7 years of relevant work experience in the biotechnology, pharmaceutical or medical device industries, including significant 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 CFR21

Part 11 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.

Salary $115,000 Plus Depending on experience