Commissioning Qualification Validation Engineer

PSC Biotech® Corporation; City of Melbourne; On-site; AUD 80,000 - 100,000; Full time

Job summary

PSC Biotech® Corporation is seeking a Commissioning, Qualification, and Validation (CQV) Engineer to join our team in Melbourne, Australia on a 12-month contract. The CQV Engineer will be instrumental in validating GxP facilities and equipment, ensuring compliance with industry standards. Candidates should have a Bachelor's degree in a relevant field and at least 3 years of experience in the biotechnology industry, including 2 years in a GMP environment. Strong communication skills and attention to detail are essential for this role.

Qualifications

• Minimum 3 years experience in biotechnology or pharmaceutical industries.
• At least 2 years of CQV experience in a GMP environment.
• Proficient in risk-based validation approaches.

Responsibilities

• Commission and validate GxP facilities and equipment.
• Draft and execute validation documentation.
• Conduct FAT/SAT, IQ, OQ, and PQ.

Skills

CQV activities

GMP compliance

Risk assessment

Validation documentation

Project proficiency

Attention to detail

Strong communication skills

Education

Bachelor's Degree in science or engineering

Job description

Your Role

We are looking for a Commissioning, Qualification, and Validation (CQV) Engineer to join our team on a 12-month contract. The CQV Professional will work alongside a talented PSC Biotech team in an exciting, developing, and diverse biotechnology landscape.

• Commission, qualify, and validate GxP facilities, equipment, and utilities in assigned projects.
• Responsible for protocol writing and execution: draft, execute, review, and approve validation documentation ensuring the documentation meets cGMP requirements, regulatory requirements, and quality standards.
• Draft and execute validation documentation such as:
  • Validation Project & Master Plans
  • Requirement Specifications (URS, DS, FS)
  • IQ and OQ Test Scripts
  • IQ/OQ/PQ Protocols
  • Validation Summary Report
• 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.
• Clearly communicate all progress, updates, and action steps for assigned projects, collaborating with multiple departments on assigned project activities and deliverables.
• Additional duties as assigned.

Qualifications

• Bachelor's Degree in a relevant science or engineering field, or equivalent years of hands‑on experience.
• 3+ years’ experience in the biotechnology and pharmaceutical industries with a minimum of 2 years relevant experience performing CQV activities within a GMP environment.
• Sound industry knowledge, project proficiency, and autonomy expected.
• Experienced in CQV of facility/utility/equipment, including PW, HVAC, and process or laboratory equipment, etc.
• Understands current risk‑based validation approaches.
• Experience in authoring, revising, reviewing, and completing controlled documents for validation projects.
• Experience with system impact assessment and risk assessment.
• Good knowledge of the code of GMP and PIC/S code.
• Previous experience in the Life Sciences Industry is required.
• Previous experience in GxP Industries is required.
• Must be adaptable, customer service oriented, and have a positive attitude.
• Excellent organizational skills.
• High attention to detail.
• Must have strong written and verbal communication skills.

Equal Opportunity Employment Statement

PSC is committed to a policy of Equal Employment Opportunity with respect to all employees, interns, and applicants for employment. Consistent with this commitment, our policy is to comply with all applicable federal, state and local laws concerning employment discrimination. Accordingly, the Company prohibits discrimination against qualified employees, interns and applicants in all aspects of employment including, but not limited to: recruitment, interviewing, hiring (or failure or refusal to hire), evaluation, compensation, promotion, job assignment, transfer, demotion, training, leaves of absence, layoff, benefits, use of facilities, working conditions, termination and employer-sponsored activities and programs, including wellness, social and recreational programs. Employment decisions will be made without regard to an applicant’s, employee’s, or intern’s actual or perceived: race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), national origin, age (40 or older), disability, genetic information, or any other status protected by law.