Validation Lead

2 weeks ago

Mulgrave, Australia Pfizer Full time

The Validation lead will be responsible for coordination and managing a validation team for new facilities and equipment and changes to existing equipment and facilities requiring capital.

New opportunity in Pfizer Melbourne (SBO) as a result of Construction of a new Facility and on-going pipeline projects.

The role is an onsite role however are many opportunities to align and network with Global Engineering and Pfizer sites across the globe.

The role will require an enthusiastic individual with passion to ensure we are always seeking best in class execution.

We are currently seeking enthusiastic Validation Lead with experience in:

- Facility Commissioning and Qualification/Validation
- Utility Qualification/Validation
- Equipment commissioning and Qualification/Validation
- Validation of Automated systems/Computer system validation.

Why Patients Need You

Whether you are involved in the design and development of manufacturing processes for products or supporting maintenance and reliability, engineering is vital to making sure customers and patients have the medicines they need, when they need them. Working with our innovative engineering team, you will help bring medicines to the world even faster by imagining what’s possible and taking action.

What You Will Achieve

The Projects Lead (Validation) is responsible for management of qualification activities and identifying key risks and presenting issues, recommendations and updates to the appropriate governance forum or process.

The scope of accountability includes liaison with contractors, suppliers, internal customers, and management/overview (as agreed) of the qualification/validation activities through to routine use.

The scope of accountability includes initial validation/qualification activities and progression to routine requalification.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. You will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members that helps in problem solving, coach them in fulfilling their day to day responsibilities and also manage their overall development by arranging training and development programs.

It is your hard work and focus that will make Pfizer ready to achieve new milestones and help patients across the globe.

How You Will Achieve It- Manage multiple projects/ ongoing work activities of moderate complexity.- Required to manage capital project qualification/validation activities according to the CPA agreed timings and outcomes.- Contribute to generation of User requirements for equipment, facilities and services.- Liase directly with Technical Service Manager ,principal engineers and Quality ensuring alignment on strategy and technology selection.- Develop of validation strategies and validation master plans for facilities (CNC to Grade A to support sterile filling), utilities and manufacturing equipment (vial wash, dry heat tunnel, filling, freeze drying decontamination), packing lines, laboratory equipment and computer systems.- Integrate qualification activities to Pfizer quality management systems- Provide leadership and line management to the team, coordinating and overseeing their workloads, providing support to ensure that the team delivers effective and efficient services.- Perform assessment of change controls for impact on validation status and actions required. Perform validation activities in accordance with Quality Management System, Validation Master Plan and Validation procedures.- Facilitate, educate and partner with production management and colleagues to lead a culture of standard work and continuous improvement efforts.- Lead improvement projects to deliver results in cost reduction, quality, supply or safety.- Manage and reviewstatus of ongoing projects, progress with developing new projects, tracking or benefits of completed projects and sets priorities.- Support the development of talent and capabilities of your team members and seek out training & development assignments for individuals who are capable of advancing to other positions.

**Qualifications**:
Must-Have- A relevant science or engineering tertiary qualification and 8+ years of experience.- Proficiency in Excel / Word / Outlook / Project/ CAD (or equivalent).- Strong analytical and problem-solving skills.- Good people management skills.- Good communication skills, proactive, good initiative and ability to work under pressure- Strong understanding of quality systems and cGMP regulatory requirements- Experience with regulatory expectations and inspections (FDA, TGA, MHRA etc)- Experience in the conduct of safe works management and EHS Compliance, particularly for capital related facility works

Personal Competencies- Good interpersonal skills inclu

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