Senior Csv Engineer

Pqe Group; City of Melbourne; On-site; AUD 120,000 - 170,000; Full time

Job summary

PQE Group in Melbourne, Australia, is seeking a Senior CSV Engineer with extensive experience in pharmaceutical, medical device, or life sciences manufacturing environments to support projects locally. You will be responsible for CSV activities in a regulated environment, review validation documentation, manage change control and risk assessments, and contribute to audits with cross-functional teams.

Join PQE Group to work on international projects and develop your skills in a multicultural,

Qualifications

• 5+ years of experience in Computer System Validation within the pharmaceutical industry.
• Strong knowledge of CSV lifecycle documentation and validation methodologies.
• Deep knowledge of GxP regulations (GMP, 21 CFR Part 11, EU Annex 11), GAMP5 guidelines, and data integrity principles.
• Ability to work independently in a fast-paced project environment.
• Strong problem-solving and communication skills.

Responsibilities

• Supporting CSV activities for computerized systems in a regulated (GxP) environment.
• Reviewing validation documentation and GAP assessment findings
• Performing and maintaining validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation reports.
• Managing change control, deviation management, and risk assessments related to computerized systems.
• Coordinating with cross-functional teams and vendors.
• Supporting audits and inspections related to validated systems.

Skills

CSV lifecycle

GxP knowledge

21 CFR Part 11

GAMP5

Data integrity

Communication

Independent work

Job description

Are you ready to join a world leader in the exciting and dynamic fields of the Pharmaceutical and Medical Device industries? PQE Group has been at the forefront of these industries since 1998, with 40 subsidiaries and more than 2000 employees in Europe, Asia and the Americas.

Following a new opportunity, we are currently looking for a Senior CSV Engineer with a strong experience in pharmaceutical, medical device or life sciences manufacturing enviroments, to support our projects in Melbourne, Australia.

You’ll be responsible for:

• Supporting CSV activities for computerized systems in a regulated (GxP) environment.
• Reviewing existing validation documentation and GAP assessment findings
• Performing and maintaining validation documentation including URS, FS, DS, IQ, OQ, PQ, and validation reports.
• Managing change control, deviation management, and risk assessments related to computerized systems.
• Ensuring compliance with internal procedures and industry guidelines such as GAMP5 and data integrity standards.
• Assessing data integrity and 21 CFR Part 11 compliance.
• Applying a risk-based approach to gap closure and updating risk assessments.
• Supporting audits and inspections related to computerized systems and validation activities.
• Coordinating with cross-functional teams and vendors.

About You:

• 5+ years of experience in Computer System Validation within the pharmaceutical industry.
• Strong knowledge of CSV lifecycle documentation and validation methodologies.
• Deep knowledge of GxP regulations (GMP, 21 CFR Part 11, EU Annex 11), GAMP5 guidelines, and data integrity principles.
• Ability to work independently in a fast-paced project environment.
• Strong problem-solving and communication skills.

Location: Melbourne, Australia

Availability: Full on-site

Working at PQE Group

As a member of the PQE team, you will be part of a challenging, multicultural company that values collaboration and innovation. PQE Group gives you the opportunity to work on international projects, improve your skills and interact with colleagues from all corners of the world. If you are looking for a rewarding and exciting career, PQE Group is the perfect place for you.

Senior CSV Engineer Melbourne, VIC, AU