Senior Digital Systems and Automation Engineer

Thermo Fisher Scientific — Australia · Posted ~3 hours ago

Senior Full-time Onsite Visa History ✓

Skills

Automation engineering Digital systems GMP Software systems

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Summary ✨ AI‑Generated

A senior automation engineering role focused on digital systems in a regulated manufacturing environment. The position involves improving operational technology, automation processes, and system reliability.

Highlights

Permanent engineering role working on digital transformation, automation systems, and regulated environments with global impact.

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 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 a permanent, full-time role and is based at our site in Brisbane. About the Role: 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 You'll Do: GMP Digital Systems & Business Applications 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+) principlesSupport and progress incidents, performing root cause analysis and coordinating issue resolution with Global IT and vendorsConduct audit trail reviews, user access reviews, and periodic system health checks Manufacturing Automation & Control Systems Support and coordinate activities for plant automation systems including PLCs, HMIs, SCADA, and equipment control platformsAct as a primary supporting contact for assigned automation systems, working with vendors, system integrators, and engineering teams to progress system changes, upgrades, and issue resolutionPerform and coordinate troubleshooting and issue resolution through appropriate internal and external resourcesSupport automation platforms such as Rockwell / Allen-Bradley, Siemens, DeltaV / TruBio, and bioprocess systems (e.g. UNICORN, MFCS) or equivalentSupport execution of automation-related activities are executed in accordance with site standards, change control, and validation requirementsProvide subject matter expertise for assigned systems and guide internal stakeholders on best practice use and improvements System Lifecycle & Continuous Improvement Lead lifecycle coordination for assigned systems, operating within Engineering and Automation governance frameworksMaintain and update enhancement backlogs, supporting prioritization discussions.Identify and communicate risks related to system obsolescence, compliance, or integration gapsProvide technical input to site planning discussions.Contribute to continuous improvement initiatives (PPI) Projects, Commissioning & Validation Coordinate and actively contribute to delivery of approved enhancements, upgrades, and project initiatives in collaboration with engineering and automation leadershipCoordinate and support automation activities across the equipment lifecycle, including design input, commissioning, qualification, and operational handoverLead site-facing FAT/SAT coordination and readiness activitiesContribute to validation activities including risk assessments, automation impact assessments, IQ/OQ/PQ, and associated documentationSupport digital validation platforms (e.g. Kneat) where applicable Compliance & Risk Management Execute compliance activities in accordance with approved proceduresAuthor and maintain validation and technical documentationSupport and ensure system and automation changes follow approved change control and governance processesParticipate in internal and regulatory auditsEscalate risks appropriately within established governance frameworks.Provide guidance on GMP and data integrity expectations for assigned systems Education Bachelor’s degree in Engineering, Information Technology, Computer Science, or related discipline. Experience 3-5 years’ experience in GMP-regulated manufacturing environments (pharmaceutical, biotech, or similar)Experience supporting manufacturing automation platform (PLC/SCADA) is requiredExperience working across IT and OT environments, with depth in at least one domainExperience in Computer System Validation (CSV)Experience supporting commissioning, FAT/SAT, and equipment qualification activities Knowledge, Skills, Abilities Strong understanding of GMP, GAMP 5, and Data Integrity principlesStrong troubleshooting, problem-solving, and root cause analysis capability across IT and OT systemsAbility to manage multiple systems and priorities in a complex environmentStrong documentation and change management discipline.Ability to work effectively in a cross-functional, site-based environmentContinuous improvement mindset with a focus on quality and complianceClear written and verbal communication skillsAlignment with Thermo Fisher Scientific 4i Values: Integrity, Intensity, Innovation, and Involvement Other Important Information This is an on-site role based at the Brisbane manufacturing facilityOccasional 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 125,000+ 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. 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.