Operation Technical Specialist at THERMO FISHER BIOPHARMA SERVICES PTE LTD

City of Brisbane, Queensland, Australia -

Full Time

Start Date

Immediate

Expiry Date

23 Feb, 26

Salary

0.0

Posted On

25 Nov, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CgmP Experience, Technical Knowledge, Cell Culture, Harvest Operations, Downstream Processing, Written Communication, Verbal Communication, Organizational Skills, Microsoft Office, SFLMS, eDMS, Trackwise, SAP, Troubleshooting, Training Development, Continuous Improvement

Industry

Biotechnology Research

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, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) Job Description As part of the Patheon / 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! About us Brisbane site, part of Pharma Services Group, focuses on GMP manufacturing of biologics for various pharma sectors globally. Job Title: Operations Technical Specialist Reports to: Operations Technical Support Manager Career Band: Band 5 Position Location: Brisbane, Australia Number of Direct Reports: 0 How will you make an impact? Engage in onboarding and training for new and existing Operations staff, offer troubleshooting expertise, and aid in operational reliability projects. Key Responsibilities Works safely in accordance with EHS guidelines and adhere to Patheon cGMP Quality Management System requirements. Develop expertise, stay current, take initiative in growth opportunities to improve skills for the role. Support batch execution and provide troubleshooting for site KPIs like Right First Time and On Time Delivery. Establishes and maintains the training programs to support the balanced growth and development of the Operations group. Builds partnerships and works collaboratively with the Operations group to develop trainee-focused content to improve operational success and sustainability. Accomplishes training as needed for both new hires and established employees. Exhibits positive conduct through the implementation of the 4i values and promotes this behavior during the training & development of the Operations team members. Tracks and trends the qualified status of Operations staffs to maintain training compliance. Write and update standard operating procedures and work instructions for processes using the Electronic Document Management System. Assists Operations group with deviation investigation and determination/implementation of preventative/corrective actions. Devises PPI initiatives to drive continuous improvement in Operations. Knowledge, Skills, Abilities Must have significant cGMP experience and technical knowledge in Cell Culture, Harvest Operations, or Downstream Processing. Hands-on experience in large-scale GMP Downstream Processing is preferred. Have excellent written & verbal communication skills. Ability to work under pressure on multiple tasks and manage priorities independently. Have strong organizational skills and a dedication to excellence. Preferred to be educated to minimum degree level in Biology, Chemistry or related field. Sufficient knowledge of Microsoft packages i.e. Word, Excel, PowerPoint, Microsoft Teams. Use of SFLMS, eDMS, Trackwise, SAP. 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. Thank you for your interest as you consider starting a new career journey with us. As the world leader in serving science, our colleagues develop critical solutions through innovation—and build rewarding careers. Discover their extraordinary stories and connection to our Mission to enable our customers to make the world healthier, cleaner and safer. Their work is a story of purpose. What story will you tell? Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation. Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.

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Responsibilities

Engage in onboarding and training for new and existing Operations staff while providing troubleshooting expertise. Support batch execution and maintain training compliance for the Operations group.