Job Description

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

At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work. Surrounded by collaborative colleagues, you’ll have the support and opportunities that only a global leader can give you. Our respected, growing organization has an exceptional strategy for the near term and beyond. Take your place on our strong team and help us make significant contributions to the world.

The network of Patheon’s drug substance manufacturing sites includes St. Louis, USA, Groningen, Netherlands and Brisbane, Australia. The performance of each manufacturing site is linked closely to the timely introduction of new projects, right first time manufacturing, and the on time delivery of products to customers.

As a Process Engineer (DSP) you will oversee successful transfer and implementation of new projects, successful delivery of commercialization of existing projects, drive harmonization of industry best practices, assist with corporate projects and lead site-related deviations/issue resolution. You will be a highly motivated self-starter who is able to assimilate new information quickly and who enjoys working collaboratively with others within a fast-paced project execution environment.

Key Tasks & Responsibilities:

Project Delivery, Technology Transfer and NPI

• Oversee successful introduction and execution of New Product Introductions (NPI’s) for our customers.
• Ensure that new processes and process improvements are successfully transferred from Process Development or an external customer to Operations.
• Technology transfer, facility fit and implementation of new production processes and providing direction to the development sites regarding overall facility fit.
• Support design, execution and roll-out of early and late phase customer projects on site. Assist in generation of the Process Control Strategy (PCS) and involvement in process risk assessments, and Process Validation documents.
• Support late phase process validation programs.

Operational Support, Troubleshooting and Investigations

• To provide onsite technical support for manufacturing scale processes across the Patheon network.
• Lead hands on troubleshooting efforts and root cause investigations to resolve deviations related to the equipment, process or product.
• Communicate the outcome of any investigation to internal and external customers.
• Ensure delivery on all relevant key KPI’s for the BNE site and BIO network.

Quality, Compliance and Regulatory Support

• Lead technical role in site and support regulatory audits.
• Generate, review and approve GMP documentation including Standard Operating Procedures (SOPs), Technical Transfer documents, Process Control Strategies (PCS), process risk assessments, Validation Protocols/Reports Master Batch Records, Process Flow Diagrams, Risk Assessments and Bills of Materials.

Continuous Improvement, Harmonisation and External Engagement

• Actively engage in PPI improvement initiatives within the team and network.
• Identify improvements and share best manufacturing practices across the internal and external network including representing TFS at conferences.
• Drive implementation of global alignment initiatives.

Technology and Equipment Implementation

• Implement new technology and equipment within the production facility.
• Assisting OPS in assessing and introduction of new equipment.

Frequent Contacts:

Internal

Operations, QA, QC, WHS, EHS, Global, SLT, BU

External

Vendors, Clients, Regulatory Bodies

Minimum Requirements/Qualifications:

Qualifications & Experience:

• Tertiary degree in Engineering (preferably chemical, biotechnology, biochemistry, chemistry)
• 3+ years of experience in a biopharmaceutical GMP manufacturing environment or a Process Development lab / pilot plant.
• Knowledge of process development, scale-up and cGMP manufacturing of protein-based pharmaceuticals
• Experience with single-use equipment and the use of automated process equipment within a GMP environment.
• This role must have expertise in the scale up of downstream purification unit operations including chromatography and all types of filtration.
• Knowledge of FDA/EMA regulatory requirements applicable to biologics. Ability to apply GMP regulations and other international guidelines to all aspects of the position.
• Technical knowledge of biopharmaceutical manufacturing, validation, raw materials, analytical testing, and materials management is desirable

Skills & Attributes:

• Strong analytical and problem-solving skills coupled with the ability to work both independently and in a team environment.
• Ability to work in a matrix management system and influence and negotiate collaboratively with others without direct authority
• Experienced in participating and leading process improvement and PPI Kaizen projects.
• Self-driven and results oriented
• Strong interpersonal and communications skills; written and oral, and a demonstrated ability to make key decisions.
• Client Communication experience is preferred.
• Proficient with computer (MS Office) and internet skills. Working knowledge of controlled documentation and data systems.

Other Important Information

• Possesses right to work in Australia

Other Job Requirements:

• Adhere to OHS policies and procedures and ensure a safe and healthy workplace environment
• Your position may require you to participate in on call work. If you are on call you are required to be available for immediate return to work outside of your normal and regular work pattern. Should this be a requirement of your position, you will be remunerated per the Company’s policy.

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