Commissioning Qualification Validation Engineer

1h1 hour ago

PSC Biotech

Brisbane, AU · Full-time · A$100,000 – A$130,000

About this role

PSC Biotech provides the life sciences with essential services to ensure that health care products are developed, manufactured, and distributed to the highest standards, in compliance with all applicable regulatory requirements. We are looking for a Commissioning, Qualification, and Validation (CQV) Engineer to join our team.

In this role, you will commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects. You will be responsible for protocol writing and execution, drafting and executing validation documentation such as Validation Project & Master Plans, Requirement Specifications, and IQ/OQ/PQ Protocols.

You will work alongside a talented PSC Biotech Team in an exciting, developing, and diverse biotechnology landscape. Our global team of skilled professionals spans strategically located offices in North America, Europe, Asia-Pacific, and the Middle East.

We are firm believers in coaching and developing the next generation of industry leaders and influencers. At PSC Biotech, it's about more than just a job—it's about your career and your future, with tools to help you grow and learn.

Requirements

Experience in commissioning, qualification, and validation of GxP facilities, equipment, and utilities
Proficiency in protocol writing and execution for cGMP environments
Knowledge of regulatory requirements and quality standards for pharmaceutical and biotechnology industries
Experience drafting Validation Project & Master Plans, Requirement Specifications, and IQ/OQ/PQ Protocols
Ability to initiate and coordinate risk analyses and design reviews
Experience executing FAT/SAT, IQ, OQ, and PQ protocols
Skill in conducting preventative maintenance and risk assessments
Ability to establish validation standards and develop performance testing and quality control measures

Responsibilities

Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects
Draft, execute, review, and approve validation documentation ensuring compliance with cGMP requirements, regulatory requirements, and quality standards
Draft and execute validation documentation including Validation Project & Master Plans, Requirement Specifications (URS, DS, FS), IQ and OQ Test Scripts, IQ/OQ/PQ Protocols, and Validation Summary Reports
Initiate and coordinate risk analyses, design reviews, and execute FAT/SAT, IQ, OQ, and PQ
Conduct preventative maintenance and perform risk assessments
Recommend process improvements where needed ensuring compliance with industry standards
Establish validation standards and develop performance testing and quality control measures
Execute process equipment and clean room validation

Benefits

Opportunity to work alongside a talented global team in a diverse biotechnology landscape
Coaching and development programs to grow as an industry leader
Compensation and benefits structure that rewards your contributions
Tools and resources to help you grow and learn in your career