Computer System Validation

**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