Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

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 on site in Brisbane and sits within the Biologics MSAT Department.

About the Role:

In this role you'll have the opportunity to contribute to world-class biopharmaceutical manufacturing. You'll get a taste of what it's like to be part of an outstanding manufacturing facility that promotes excellence, fosters inclusive environments, and values a culture of quality and make a significant impact within the Biologics MSAT Department.

What You'll do:Successfully introduce and complete new customer projects (NPI’s)Ensure seamless transfer of new processes and improvements from Process Development or external customers to OperationsAchieve and surpass important performance indicators for the BNE site and BIO networkEngage actively in PPI improvement initiatives within the Process Engineering team and Technology Transfer networkProvide onsite technical support for manufacturing scale processes across the Patheon networkLead problem solving efforts and root cause investigations to resolve equipment, process, or product deviationsCommunicate investigation outcomes to internal and external customersDirect development sites on the facility fit of new processesSupport late-phase process validation programsIdentify and share best manufacturing practices across the networkIntroduces new processing technologies in an ever-growing facilityCo-ordinate technology transfer, facility fit, and implementation of new production processesGenerate, review, and approve GMP documentation including SOPs, Technical Transfer documents, Master Batch Records, Process Flow Diagrams, Risk Assessments, and Bills of MaterialsImplement new technology and equipment within the production facility

Keys to Success:

Education:

Degree in Biomedical Engineering or equivalent

Knowledge, Skills and Experience:

At least 3-5 yrs experience within an operations biologics manufacturing environmentExperience in developing and scaling up all downstream unit operationsStrong knowledge of GMPTraining in leading Tap Root investigations or equivalent Root Cause Analysis methodologyStrong analytical and problem-solving skills, with the ability to work independently and within a teamExperience in matrix management systems, influencing and leading collaborative discussions without direct authorityParticipation and leadership in PPI Kaizen projectsDedicated and goal-focusedKnowledge of FDA/EMA regulatory requirements applicable to biologics and the ability to apply GMP regulations and international guidelinesStrong interpersonal and communication skills - both written and verbalStrong experience of interacting and collaborating with external clientsTechnical knowledge of bio-pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials managementProficiency with MS Office and internet skills, with a solid understanding of controlled documentation and data systems

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.