Supports commissioning, qualification, and validation of pharmaceutical and biomedical facilities, utilities, and equipment. Authors and executes DQ, FAT, SAT, IQ, OQ, PQ, and PV documentation; develops SOPs and validation reports; performs risk analyses and design reviews; ensures cGMP, GDP, and data integrity compliance; coordinates vendors, contractors, and cross-functional teams; manages project activities, timelines, and status reporting; and mentors clients and junior engineers.
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:
· 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.
· 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.
· 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.
Requirements
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.
· 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.
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What you need to know about the Melbourne Tech Scene
Home to 650 biotech companies, 10 major research institutes and nine universities, Melbourne is among one of the top cities for biotech. In fact, some of the greatest medical advancements were conceptualized and developed here, including Symex Lab's "lab-on-a-chip" solution that monitors hormones to predict ovulation for conception, and Denteric's vaccine for periodontal gum disease. Yet, the thousands of people working in the city's healthtech sector are just getting started, to say nothing of the tech advancements across all other sectors.
