Quality Assurance Engineer – GMP & Validation (12-Month)

PSC Biotech; Melbourne; Hybrid; AUD 90.000 - 130.000; Vollzeit

Zusammenfassung

PSC Biotech in Melbourne, Australia is seeking a Quality Assurance Engineer for a 12-month contract. The QA Engineer will provide QA oversight for commissioning, qualification, validation, technology transfer, process lifecycle management, and related activities to ensure overall quality and regulatory compliance throughout the project lifecycle.

This role requires strong GMP/GxP knowledge, risk-based decision making, and the ability to collaborate with Engineering, Manufacturing, Validation,

Qualifikationen

• Bachelor's degree in Engineering or Life Science.
• Minimum 4 years in QA, Validation or related fields in regulated industries.
• Experience reviewing GMP docs including risk assessments and validation protocols.
• Experience supporting technology transfer and process validation.
• Working knowledge of cGMP, GxP and international regulatory requirements.
• Strong technical writing and document review skills.
• Ability to build relationships across multiple functions.

Aufgaben

• Provide QA oversight for engineering, validation, manufacturing and capital projects.
• Review and approve GMP documents including protocols, risk assessments and CAPAs.
• Support commissioning, validation, technology transfer and lifecycle activities.
• Facilitate deviations, investigations, change controls, CAPA and risk management.
• Ensure compliance with cGMP, GxP and regulatory requirements.
• Provide quality guidance and risk-based decision making to teams.
• Collaborate with engineering, manufacturing, validation, Quality Control, Supply Chain and Regulatory teams.
• Participate in audits, inspections and continuous improvement initiatives.
• Support vendor qualification and supplier quality activities.
• Additional duties may be assigned.

Kenntnisse

Quality Assurance

GMP Knowledge

Technical Writing

Relationship Building

Problem Solving

Interpersonal Awareness

Agility

Risk Management

Ausbildung

Bachelor’s Degree in Engineering or Life Science

Jobbeschreibung

Melbourne, Australia | Posted on 07/08/2026

We are looking for a Quality Assurance Engineer to join our team on a12-month contract. The Quality Assurance Engineer is responsible forproviding Quality Assurance oversight and support for commissioning,qualification, validation, technology transfer, process lifecycle management,capital projects, vendor qualification, and operational quality activities.This role is accountable for maintaining quality and compliance throughout theproject lifecycle while supporting successful project execution and commercialoperations. The incumbent is also responsible andaccountable for the execution of the PSC mission, “to maintain the integrityand professionalism of our products and services while enabling steady growthand development”.

D U T I E S A N D R ES P ONSIBI L IT IE S :

· Provide Quality Assurance oversight forengineering, validation, manufacturing, and capital project activities.

· Review and approve GMP-related documents,including validation protocols, qualification documents, risk assessments,technical transfer documentation, and quality system records.

· Support commissioning, qualification,validation, technology transfer, and process lifecycle activities to ensurecompliance with regulatory and company requirements.

· Facilitate and support quality systemsincluding deviations, investigations, change controls, CAPA, and riskmanagement activities.

· Ensure compliance with cGMP, GxP, siteprocedures, and applicable global regulatory requirements.

· Provide quality guidance and risk-baseddecision-making to project teams and operational stakeholders.

· Collaborate with Engineering, Manufacturing,Validation, Quality Control, Supply Chain, and Regulatory teams to achieveproject and business objectives.

· Participate in audits, inspections, andcontinuous improvement initiatives to maintain and enhance compliance andquality performance.

· Support vendor qualification and supplierquality activities as required.

· Additional duties and responsibilities may beassigned from time to time.

DE M O N S TR A T E D C O M P E T E N CI ES :

• Quality &Compliance Excellence – Strongunderstanding of cGMP, GxP principles, quality systems, validation lifecyclerequirements, and global regulatory expectations.
  
• Relationship Building – Works with and acrossformal and informal professional and social networks to build long-termpartnerships and connections in the life science industry.
  
• Problem solving –Identifies, researches, and demonstrates logical reasoning to communicatecritical information.
  
• Rational Persuasion –, Active listening, Presents key factors influencing factors, andstrategic goals to assist stakeholders in identifying solutions.
  
• Interpersonal Awareness – Ability to be aware ofhow actions, ideas, and communication can/does affect people and theiroutcomes.
  
• Agility – Meets objectives by responding to competingand changing priorities and multiple 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’s Degree in Engineeringor Life Science.
  
• Minimum 4 yearsof experience in Quality Assurance, Validation, , Manufacturing Quality, orProject Quality within the pharmaceutical, biotechnology, medical device, orother regulated industries.
  
• Demonstratedexperience reviewing and approving GMP documentation including riskassessments, validation protocols, qualification documents, change controls,deviations, and CAPAs.
  
• Experiencesupporting technology transfer, process validation, qualification, engineering,manufacturing, or capital projects.
  
• Working knowledge of cGMP, GxP, FDA, EMA, TGA, PIC/S, andinternational regulatory requirements.
  
• Strong technical writing and document review skills.
  
• Ability tobuild and maintain relationships with stakeholders across multiple functionsand organizational levels.