Senior Validation Engineer

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

About us:

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Location/Division Specific Information

This role is based onsite in our Brisbane office and does offer Hybrid working options once initial training has been completed. The Thermo Fisher Scientific site in Brisbane is a multi-product biopharmaceutical site with development and manufacturing facilities for pharmaceutical products for clinical trials (Phase I, II and III). The extent of the application of the c-GMP system and the degree of testing varies with the stage of the product. The validation department is responsible for the validation of manufacturing equipment, analytical instrument, utilities, facilities, computerised systems and processes including cleaning.

About the Role:

Manufacturing of biopharmaceutical products is required to follow international quality requirements as defined by TGA, FDA, EMA and other regulatory agencies as applicable. In order to achieve these requirements, the Senior Validation Engineer will be focused on assisting Equipment, Utilities and Facilities Validation departments in maintaining expected lifecycle approaches in accordance with regulatory guidelines, the Site Validation Master Plan, project specific Validation Plans, and departmental SOPs. It's also expected that this role will also provide advisory relationships to other validation engineers/contractor who work as part of the team.

What You'll do:

• Assist Validation Department and provide Validation SME guidance for commissioning and qualification of Equipment, Facilities and Utilities, in compliance with pertinent regulations (e.g., TGA, FDA, EMA)
• Co-ordinate validation protocol execution status and ensure completion of validation activities per required schedules
• Preparing, execution and/or review of validation documentation, including and not limited to FDS, DQ, IOQ PQ, CSV etc.
• Track and resolve anomalies during qualification activities.
• Assist project managers with development of project plans for validation processes
• Represent Validation at external and internal audits
• Responsible for performing validation activities and achieving:
  • assigned targets, standards and/or departmental goals
  • priorities in the planning of actions and resources
  • strategic goals set for the department, which are in line with the company goals
  • yearly plans of the department

• Responsible for external technological, legal and regulatory developments around Validation and assess their applicability to and consequences for Brisbane site
• Collaborate with validation teams in other in-house Biologics sites to identify and implement standard methodologies
• Responsible for contributing to validation process continuous improvement in costs and results within validation activities
• Collaborating with onsite contractors to meet current and future requirements, in terms of quality and quantity, to establish and maintain cGMP compliance
• Lead the execution of relevant validation activities within the Manufacturing and Laboratory areas, integrating their timeline with ongoing projects and programs
• Responsible for EH&S in assigned Validation activities, including maintaining a safe and balanced working environment, Champion the awareness for EH&S and Quality within department

Keys to Success:

Education:

• Bachelor’s Degree in Science, Engineering or Statistics - and/or equivalent industry work experience

Skills and Experience:

• Preferably 5 years industry work experience within a Biotech validation environment in a commercial scale manufacturing operation
• A Quality mentality with the ability to interpret and apply GMP principles
• Strong communication and interpersonal skills – both written and verbal
• Good presentation, planning, and organisational skills, attention to detail and dedication to quality orientation principles.
• Proven leadership and mentorship capabilities (preferred for future career growth), with the ability to multi-task and meet agreed delivery timelines.
• IT foresight and adaptability
• Ability to collaborate with complimentary teams
• Demonstrated dedication to continuous improvement and focus on customers

Attributes:

• IT acuity: Comfortable with the use and administration of various types of software packages
• Adaptability: Ability to adapt to day-to-day business requirements.
• Collaborating: Ability to work with all departments and colleagues of varied backgrounds.
• Continuous Improvement: Demonstrates the ability to challenge the status quo to drive continuous improvement.
• Customer Focus: The ability to deliver on promises made to customers. i.e. meet agreed due dates.
• Initiating Action: Ability to work independently, and manage planned work. Ability to work on multiple projects or tasks simultaneously.
• Managing Relations: Demonstrates capability to manage customer demands with respective business requirements and agreed timelines.
• Quality Orientation: Ability to interpret and apply GMP principles, strong attention to detail and accurate completion of test records. Strives for right first time in every task undertaken.
   

Other Job Requirements:

• Abide by all EH&S policies and procedures
• Work safely and only perform tasks if currently competent and/or authorised.
• Report hazardous conditions, hazardous actions, incidents and near-miss incidents.
• Participate in EH&S activities (such as inspections and risk assessments).
• Not knowingly pollute the environment.

Benefits:

Join our team and take advantage of these great benefits! Apply now to learn more about the full range of benefits we offer.

• Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-related issues.
• Flexibility: Balance your work and personal life with flexible arrangements.
• Extra Leave: Benefit from generous leave policies, including the option to purchase additional leave, paid birthday leave, and company paid parental leave.
• Charitable Giving & Volunteering: Make an impact with paid volunteer time to support non-profit organizations that matter to you.
• Learning & Development: Advance your career with access to online courses via Thermo Fisher Scientific University Plus and LinkedIn learning, workshops, and mentorship programs for continuous learning and skill development.

Thermo Fisher Scientific Australia WGEA Employer of Choice for Gender Equality

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Apply today! http://jobs.thermofisher.com

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.