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Validation Lead
3 months ago
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.
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.
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.
As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services.
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.
Personal Competencies- Good interpersonal skills inclu
