Computer System Validation

2 weeks ago

Melbourne, Australia PQE Australia Pty Ltd Full time

**About the business and the role**

We are a service provider company, leader in the **Pharmaceutical and Medical Device sectors** since 1998, with **more than 2000 employees, 45+ nationalities and 32 offices all over the world (Europe, Asia and the Americas).** Joining PQE means being a part of a multicultural and challenging company, with many local and international projects, and colleagues from all over the world.

Due to a constant growth, PQE is looking for a Computer System Validation Automation Consultant based in **Melbourne, Australia.**

**Core responsibilities**:
Operate as Expert in Computer System Validation, with focus on Automation systems, within on Field projects performed in pharmaceutical, biotechnology and engineering environment in Australia as well as operative team lead for testing activities and documental review.

The main activities listed below will be carried out autonomously as a single lead stakeholder or within a multidisciplinary team to be coached.

**1.** **Computer System Validation**

1.1 Development of Data Integrity Compliance Assessment Plans

1.2 Execution of Field Assessment activities as Assessor (including the organization of onsite workshops to share the outcome of assessment activities)

1.3 Definition of possible strategies to outline remediation action plans/projects

1.4 Development of Validation Plan

1.5 Development and Review of Validation Technical Documentation (User Requirement Specifications, Configuration & Design Specifications)

1.6 Execution of a System Risk Assessment

1.7 Preparation and on Field Execution of Validation Testing Protocols (IQ, OQ, PQ)

1.8 Development of Validation Summary Report and Traceability Matrix

**2.** **Automation**

2.1 Looking after complete Routine maintenance of plant equipment

2.2 Preparation, review of Document like concept note, URS, configuration specification(CS), functional specification(FS), Risk assessment, DQ ,IQ ,OQ, GXP assessment and CCR

2.3 Trouble Shooting of PLC & SCADA Related Issues

2.4 Design, write, and implement, test and document PLC and HMI software

2.5 Develop standards for PLC logic/designs and develop PLC program based on process input / FDS

2.6 Develop standards sets of SCADA interface screen that will support industrial products/systems

2.7 Perform on Field testing/ simulation/ FAT/SAT/Commissioning

**3.** **Project Management**

3.1 Conduct extensive review of Validation documentation

3.2 Manage teams for Validation activities

3.3 Provide expertise for Validation documentation issuing

3.4 Definition of a project plans/GANTT

3.5 Management of Resources workload plans, technical problems and budget monitoring.

**Skills Required**:

- Technical Degree (Pharmacy, Pharmaceutical Chemistry, Microbiology, Chemistry, Engineering)
- Experience with Karl Fischer apparatus
- 3 years of experience in Pharmaceutical industry
- Write Cleaning Validation protocols and reports, execute, interpret, and evaluate validation documents in terms of acceptability to industry standards (GMPs, FDA Guidelines), procedures, and regulatory requirements such as but not limited to (21 CFR Parts 210, 211, etc...)
- Knowledge of De-Pyrogenation Tunnel Qualification
- Knowledge of FT-IR Spectrophotometer
- Good knowledge of US cGMP (21 CFR Part 210-211), and EU cGMP (Eudralex Volume 4 and Annexes)
- English Fluent (mandatory)
- Product matrix (TD & 10 ppm & PDE criteria)
- Full availability to travel domestically and abroad

**Nice to have**:
Knowledge of Spanish (fluent)

**Salary**: $85,000.00 - $90,000.00 per year

**Benefits**:

- Professional development assistance
- Work from home

Schedule:

- 8 hour shift
- Monday to Friday

Supplemental pay types:

- Performance bonus

**Language**:

- English (required)

Work Authorisation:

- Australia (required)

Work Location: In person

  • Computer Systems Validation Specialist

    3 weeks ago

    Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Organisation - Long Term Contract Validation Opportunity - Melbourne Based Location **About the company** Our client is one of the world’s leading global pharmaceutical manufacturers and suppliers of pharmaceutical related products for the local and global market. As a highly regarded & well-known organisation they are known for...

  • Computer Systems Validation Specialist

    2 months ago

    Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Organisation - Long Term Contract Validation Opportunity - Melbourne Based Location **About the company** Our client is one of the world’s leading global pharmaceutical manufacturers and suppliers of pharmaceutical related products for the local and global market. As a highly regarded & well-known organisation they are known for...

  • Computer Systems Validation Specialist

    5 days ago

    Melbourne, Victoria, Australia Bell People Consultants Full time

    Global Pharmaceutical Organisation Long Term Contract Validation Opportunity Melbourne Based LocationAbout the companyOur client is one of the world's leading global pharmaceutical manufacturers and suppliers of pharmaceutical related products for the local and global market. As a highly regarded & well-known organisation they are known for their operational...

  • Quality Validation Specialist

    2 months ago

    Melbourne, Australia Ignite Specialist Recruitment Services Full time

    Our client - a multinational biotechnology research and development company is looking to hire a Quality validation specialist(computer Systems) for a 12-month contract. Reporting to the Computer System Validation Site Lead you will be responsible for senior computer system validation specialist will ensure all computerized systems used to support GMP...

  • Computer Systems Validation Consultant

    5 days ago

    Melbourne, Victoria, Australia Attribute Consulting Full time

    Leading Melbourne based medical/pharma company with a global presence Work with a diverse group of Scientists, Project Managers and QA professionals Long term contract where you can create your own footprint within the company.The Company:Melbourne based consulting company that delivers a multitude of solutions across best-practice advice, training, software...

  • Validation Analyst

    2 weeks ago

    Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Organisation - Long Term Contract Opportunity - Melbourne Metro - Hybrid Role - WFH & Office Based **About The Company** Operating as a major global Multinational pharmaceutical manufacturer with global sites worldwide, our client is well known for its growth and innovation and is an Australian iconic brand in the marketplace,...

  • Quality Validation Specialist

    5 days ago

    Melbourne, Victoria, Australia https:www.bebeejoin Full time

    Our client - a multinational biotechnology research and development company is looking to hire a Quality validation specialist(computer Systems) for a 12-month contract.Reporting to the Computer System Validation Site Lead you will be responsible for senior computer system validation specialist will ensure all computerized systems used to support GMP...

  • Quality Validation Specialist

    5 days ago

    Melbourne, Victoria, Australia Ignite Specialist Recruitment Services Full time

    Our client - a multinational biotechnology research and development company is looking to hire a Quality validation specialist(computer Systems) for a 12-month contract.Reporting to the Computer System Validation Site Lead you will be responsible for senior computer system validation specialist will ensure all computerized systems used to support GMP...

  • Validation Manager

    4 weeks ago

    Melbourne, Australia Moderna Full time

    **The Role**: Reporting to the Director, Engineering & Facilities, the Validation Manager will own the site Commissioning, Qualification and Validation (CQV) program and will be the SME for site qualification activities. This role will own the delivery of the site re-qualification and periodic review programs, ensuring systems and equipment remain in an...

  • Validation Manager

    5 days ago

    Melbourne, Victoria, Australia Moderna Full time

    The Role:Reporting to the Director, Engineering & Facilities, the Validation Manager will own the site Commissioning, Qualification and Validation (CQV) program and will be the SME for site qualification activities. This role will own the delivery of the site re-qualification and periodic review programs, ensuring systems and equipment remain in an...

  • Validation Engineer

    1 month ago

    Melbourne, Australia Australia Wide Engineering Recruitment Full time

    Join a group of automotive specialists and accelerate your career.Be part of the creation of innovative and custom solutions.United group of automotive specialists with a global presence. The Company:Our client, based in Hallam, has 30 years experience in the Automotive Industry and specialises in the concept, development, validation and production of...

  • Validation Engineer

    5 days ago

    Melbourne, Victoria, Australia Australia Wide Engineering Recruitment Full time

    Join a group of automotive specialists and accelerate your career.Be part of the creation of innovative and custom solutions.United group of automotive specialists with a global presence. The Company:Our client, based in Hallam, has 30 years experience in the Automotive Industry and specialises in the concept, development, validation and production of custom...

  • Validation Associate

    5 days ago

    Melbourne, Victoria, Australia Healthcare Professionals Group Full time

    BenefitsWorking within an international teamMonday to Friday positionExperience in validation is necessaryAbout the organizationJoin a prominent global Biotechnology company with a strong company culture that continues to grow.About the roleThis position involves executing validation tasks related to modifications in current facilities, machinery, and...

  • Validation Engineer

    2 weeks ago

    Melbourne, Australia Australia Wide Engineering Recruitment Full time

    BRW Top 50: Most innovative companiesJoin a group of automotive specialists and accelerate your careerBe part of the creation of innovative and custom solutions The Company: Our client, based in Hallam, has 30 years experience in the automotive industry and specialises in the concept, development, validation and production of custom automotive solutions...

  • Validation Engineer

    5 days ago

    Melbourne, Victoria, Australia Australia Wide Engineering Recruitment Full time

    BRW Top 50: Most innovative companiesJoin a group of automotive specialists and accelerate your careerBe part of the creation of innovative and custom solutions The Company: Our client, based in Hallam, has 30 years experience in the automotive industry and specialises in the concept, development, validation and production of custom automotive solutions...

  • IT Lab Computer Systems Associate

    2 weeks ago

    Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Organisation - Excellent Contract Opportunity - Melbourne Metropolitan Area **About the Company** Our client is one of the world’s leading global pharmaceutical manufacturers and suppliers of pharmaceutical related products for the local and overseas global market. They are well known for their operational excellence, passion for...

  • Computer and Systems Technology Teacher

    2 months ago

    Melbourne, Australia SchoolHouse Full time

    **Computer and Systems Technology Teacher | Eastern Suburbs** - Computer and Systems Technology Teacher - Ability to teach a combination of the following required: - Systems Technology - Computing - Robotics - Commencing January 2024 - Ongoing position - Co-Educationla, Catholic school - Job Reference # 3475 Our client is a large, co-educational College in...

  • IT Lab Computer Systems Associate

    2 weeks ago

    Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Organisation - Excellent Long Term Contract Opportunity - Melbourne Metropolitan Area **About the Company** Our client is one of the world’s leading global pharmaceutical manufacturers and suppliers of pharmaceutical related products for the local and overseas global market. They are well known for their operational excellence,...

  • IT Lab Computer Systems Associate

    5 days ago

    Melbourne, Victoria, Australia Bell People Consultants Full time

    Global Pharmaceutical Organisation Excellent Contract Opportunity Melbourne Metropolitan AreaAbout the CompanyOur client is one of the world's leading global pharmaceutical manufacturers and suppliers of pharmaceutical related products for the local and overseas global market. They are well known for their operational excellence, passion for innovation and...

  • Senior System Specialist

    5 days ago

    Melbourne, Victoria, Australia Solid System Team GmbH Full time

    We are seeking a talented Senior System Specialist.You will be responsible for managing and maintaining the company's IT infrastructure and ensuring the smooth operation of systems and services.Requirements Bachelor's degree in Information Technology, Computer Science, or a related field.Minimum 8 years of experience in systems administration or a similar...