Experience Inc. Jobs

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, Cold Room/Freezers -22degrees, No eye contacts allowed; prescriptive glasses will be provided, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

About Us:

Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $44 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, improving patient diagnostics and therapies or increasing efficiency in their laboratories, we are here to support them. Our team of more than 125,000 colleagues 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. For more information, please visit www.thermofisher.com

Position Summary:

Manufacturing of biopharmaceutical products is required to be in compliance with international quality requirements as defined by the TGA, FDA, EMA and other regulatory agencies as applicable. To achieve compliance, quality systems are defined, implemented and maintained. Our team is responsible for ensuring the completion of qualification/validation protocols, batch release and stability testing. We are a quickly expanding site with ever growing opportunities. We believe our workforce are our greatest asset, and are passionate about nurturing and developing future talent!

Key Responsibilities:

• Contribute to the efficient and effective operation of the QC Microbiology Laboratory.

• Perform QC microbiological testing and associated tasks including bioburden testing of process intermediates, crude harvest and drug substance and WFI.

• Perform environmental monitoring including surface monitoring, active and passive air sampling.

• Participate in activities related to analytical development and QC test strategy to meet or support the client’s requirements and/or expectations.

• Perform growth promotion testing of microbiological media used in testing.

• Responsible for stock control within the Microbiology laboratory.

• Perform all work in a safe manner adhering to EH&S safe working practices, including wearing of personal protective equipment (PPE). Conduct proactive hazard identification and report any accidents, incidents and near misses.

• Actively contribute to process improvement initiatives. Prepare, maintain and improve the quality of microbiological generated documents including SOPs, Specifications, Test Methods, Policies, Summary Reports and Investigation Reports. Initiate and implements Change Controls.

• Actively contribute to raising Change Controls, report and investigate microbiological excursions (OOS, DRs).

• Provide microbiological technical support and input into Quality related issues. Communicate effectively across departments and internal customers.

• Perform internal and external networking with other microbiologists and external specialists for benchmarking and development.

• Document all work to GMP standards.

• Perform training of QC Microbiology staff and other staff as required.

• Contribute to regulatory and client audits when required.

Skills & Experience:

• Tertiary Science qualification (either degree in a related science field or post-secondary education in an appropriate field) with experience in laboratory testing, good aseptic technique and validation required for the bio-pharmaceutical industry.

• Experience of working in a manufacturing or laboratory environment with knowledge of bio-pharmaceutical processes and pharmaceutical guidelines preferred.

• Background in Microbiology. Familiarity with principles of aseptic techniques and microbiological testing preferred.

• Knowledge of GLP, cGMP, and Quality Principles.

• Proven record of ability to work as a team member and independently as required

• Experience in multitasking, prioritizing and showing initiative to complete tasks according to company milestones.

• A track record showing good oral and written communication skills.

• Computer literate in word processing, spreadsheets and databases.

• Adaptability: Ability to adapt to daily business requirements.

• Collaborating: You will have the ability and competency to work with all departments and colleagues of varied backgrounds.

• Continuous Improvement: Drive PPI

• Quality Orientation: Ability to interpret and apply cGMP principles, strong attention to detail, and accurate completion of test records. Strives for right first time in every task undertaken.

• Deliver the best technical and scientific solutions to improve product value. Build a culture of engagement, accountability and a shared commitment to excellence.

• Abide by all EH&S policies and procedures, operate our business in a safe, focused, responsible, and ethical fashion. Work safely and only perform tasks if currently competent and/or authorised, participate in EH&S activities such as; GEMBA walks, inspections, and risk assessments.

We offer competitive compensation and benefits packages, along with opportunities for professional growth and development. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-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.

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.