Technical Services Manager

Pfizer’s purpose 'Breakthroughs that change patients’ lives’ fuels everything we do. We innovate every day to help make the world a healthier place. From scientific discovery to breakthrough products to our essential partnerships around the world, we’re committed to quality healthcare for everyone. Because every individual matters.

Why Patients Need You

Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.

What You Will Achieve

All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. In your role, you will join a team which is responsible for the establishment and execution of the validation strategy for a given sector of validation (i.e. equipment, computer system validation, continued process verification, process, cleaning, etc.) to ensure that the validation documentation is compliant with plant and corporate validation requirements and policies. More broadly, you will be joining a department which aims to foster a culture of compliance and continuous improvement amongst all personnel who operate within the Validation team.

As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your 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 and help in problem solving.

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

This position will be based at our Melbourne site.

How You Will Achieve It- Manage the routine requalification program ensuring all scheduled tasks are performed, reviewed and approved.- Manage multiple projects / ongoing work activities within the department typically involving cross-functional representatives.- Lead a team of Validation Specialists and provide guidance on planning and execution of validation activities.- Coordinate activities with clients, programmers/developers and operating personnel, identifying current and anticipated requirements for compliant computerized operations, suggesting methods for the identification, implementation and maintenance of procedures, actions and documentation necessary to assure compliance.- Ensure that appropriate systems are in place such that site operations meet or exceed the GMP requirements.- Provide leadership to site technical staff regarding the development 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, via decontamination), automate packing lines, laboratory equipment and computer systems.- Maintain validation documents including those generated during project phase.- Develop necessary programs to understand and document Critical Quality Attributes for products, Critical Process Parameters for processes and Critical Attributes for equipment.- Allocate department staffing and manage the utilization of facilities and equipment to ensure that department and site objectives are met within budget guidelines.- Enhance site technical staff’s knowledge of 21 CFR Part 11, cGAMP, cGMP and general validation principles.- Prepare and execute site internal audit program including completion of identified actions.- Develop, introduce and review practices and cultural changes that enable the department to meet business demands within agreed timeframes and expected regulatory standards.

**Qualifications**:
Must-Have- Bachelor’s Degree and 5+ years’ of experience.- People Management experience.- Extensive experience talking/dealing with regulatory and third-party representatives.- Good organizational, presentation, meeting facilitation, project/time management and technical writing skills.

Nice-to-Have- Master’s degree and relevant pharmaceutical experience.- Extensive understanding and knowledge of regulatory requirements and validation as applied to the pharmaceutical equipment and facilities.- Excellent written and verbal communication skills with the ability to interact with senior leadership and regulatory agencies.- Strong Analytical and problem solving abilities.

Work Location Assignment: On Premise

Quality Assurance and Control