Senior Digital Systems and Automation Engineer (GMP)

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team youll 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 worlds toughest challenges like protecting the environment making sure our food is safe or helping find cures for cancer.

This role is a permanent full-time role and is based at our site in Brisbane.

The Senior Digital Systems and Automation Engineer (GMP) owns day-to-day support and leads coordination of lifecycle management and continuous improvement of GMP-regulated digital systems and manufacturing automation platforms at the Brisbane site.

The role provides technical ownership for assigned systems contributing to system reliability compliance and alignment with business needs across Manufacturing Quality and Engineering.

The position works across IT and OT environments collaborating with internal teams and external partners to support integration and performance of systems supporting site operations.

What Youll Do:

• Partner with stakeholders to gather and document business requirements (URS/FRS process documentation)

• Support system availability performance and compliance with GMP and Data Integrity (ALCOA) principles

• Support and progress incidents performing root cause analysis and coordinating issue resolution with Global IT and vendors

• Conduct audit trail reviews user access reviews and periodic system health checks

• Support and coordinate activities for plant automation systems including PLCs HMIs SCADA and equipment control platforms

• Act as a primary supporting contact for assigned automation systems working with vendors system integrators and engineering teams to progress system changes upgrades and issue resolution

• Perform and coordinate troubleshooting and issue resolution through appropriate internal and external resources

• Support automation platforms such as Rockwell / Allen-Bradley Siemens DeltaV / TruBio and bioprocess systems (e.g. UNICORN MFCS) or equivalent

• Support execution of automation-related activities are executed in accordance with site standards change control and validation requirements

• Provide subject matter expertise for assigned systems and guide internal stakeholders on best practice use and improvements

• Lead lifecycle coordination for assigned systems operating within Engineering and Automation governance frameworks

• Maintain and update enhancement backlogs supporting prioritization discussions.

• Identify and communicate risks related to system obsolescence compliance or integration gaps

• Provide technical input to site planning discussions.

• Contribute to continuous improvement initiatives (PPI)

• Coordinate and actively contribute to delivery of approved enhancements upgrades and project initiatives in collaboration with engineering and automation leadership

• Coordinate and support automation activities across the equipment lifecycle including design input commissioning qualification and operational handover

• Lead site-facing FAT/SAT coordination and readiness activities

• Contribute to validation activities including risk assessments automation impact assessments IQ/OQ/PQ and associated documentation

• Support digital validation platforms (e.g. Kneat) where applicable

• Execute compliance activities in accordance with approved procedures

• Author and maintain validation and technical documentation

• Support and ensure system and automation changes follow approved change control and governance processes

• Participate in internal and regulatory audits

• Escalate risks appropriately within established governance frameworks.

• Provide guidance on GMP and data integrity expectations for assigned systems

• Bachelors degree in Engineering Information Technology Computer Science or related discipline.

• 3-5 years experience in GMP-regulated manufacturing environments (pharmaceutical biotech or similar)

• Experience supporting manufacturing automation platform (PLC/SCADA) is required

• Experience working across IT and OT environments with depth in at least one domain

• Experience in Computer System Validation (CSV)

• Experience supporting commissioning FAT/SAT and equipment qualification activities

• Strong understanding of GMP GAMP 5 and Data Integrity principles

• Strong troubleshooting problem-solving and root cause analysis capability across IT and OT systems

• Ability to manage multiple systems and priorities in a complex environment

• Strong documentation and change management discipline.

• Ability to work effectively in a cross-functional site-based environment

• Continuous improvement mindset with a focus on quality and compliance

• Clear written and verbal communication skills

• Alignment with Thermo Fisher Scientific 4i Values: Integrity Intensity Innovation and Involvement

• This is an on-site role based at the Brisbane manufacturing facility

• Occasional off-hours support or project-based flexibility may be required to support critical activities such as commissioning or equipment start-ups

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 125000 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.

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.