Process Engineer (Dsp)

Description:

Work Schedule
Standard Office Hours (40/wk)
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, Laboratory Setting, 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:
- Mentor and train Process and Support Engineers on standard methodologies within Manufacturing Sciences & Technology (MSAT).
- Coordinate the introduction and execution of New Product Introductions (NPI's) for our customers.
- Successfully transfer new processes and process improvements from Development to Operations.
- Achieve all important performance indicators for the BNE site and BIO network.
- Lead technical roles in site and regulatory audits.
- Design, complete, and roll out late phase customer projects on site, including Process Control Strategy (PCS) and process risk assessments.
- Maintain validated processes throughout the lifecycle of commercial products in partnership with Process Validation.
- Engage in PPI improvement initiatives within the team and network.
- Provide onsite technical support for manufacturing scale processes across the Patheon network.
- Lead problem solving efforts and root cause investigations to resolve deviations related to equipment, process, or product.
- Communicate investigation outcomes to internal and external customers.
- Lead technology transfer, facility fit, and implementation of new production processes.
- Support late phase process validation programs.
- Identify improvements and share best manufacturing practices across the network.
- Promote standardisation within the team, advocating for DSP standard methodologies.
- Generate, review, and approve GMP documentation, including SOPs, Technical Transfer documents, Process Control Strategies, and Validation Protocols/Reports.
- Support regulatory filings and updates for late phase and commercial projects.
- Implement new technology and equipment within the production facility.
- Assist in assessing and introducing new equipment.
- Support global alignment initiatives.
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 environment
- Experience in developing and scaling up all downstream unit operations
- Strong knowledge of GMP
- Training in leading Tap Root investigations or equivalent Root Cause Analysis methodology
- Strong analytical and problem-solving skills, with the ability to work independently and within a team
- Experience in matrix management systems, influencing and leading collaborative discussions without direct authority
- Participation and leadership in PPI Kaizen projects
- Dedicated and goal-focused
- Knowledge of FDA/EMA regulatory requirements applicable to biologics and the ability to apply GMP regulations and international guidelines
- Strong interpersonal and communication skills - both written and verbal
- Strong experience of interacting and collaborating with external clients
- Technical knowledge of bio-pharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management
- Proficiency with MS Office and internet skills, with a proven 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 (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) 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 (https://corporate.thermofisher.com/us/en/index.html) , 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.
Join us in our mission to enable our customers to make the world healthier, cleaner and safer. Apply today and start your story with Thermo Fisher Scientific!
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.