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Work Schedule:12 hr shift / days
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.
Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs, etc.).
Standing for full shift.
Position Summary:Manufacturing of biopharmaceutical products in compliance with international quality requirements as defined by TGA, FDA, EMEA, ICH, etc.
Key Responsibilities: Trained on and support execution of DSP unit operations (chromatography, virus inactivation, virus filtration, ultrafiltration-diafiltration and drug substance final fill) with the applicable production protocols and planning schedules, in a clean room environment under cGMP conditions.A pro-active attitude and personal initiative is encouraged to identify practical problems and communicate to the responsible person.Contribute in their DSP functions, such as maintaining production suite, supplies, equipment, logbooks, and data, as well as closing out batch record and material reconciliation in accordance with site SOPs and policies.Perform equipment maintenance and testing related to technical skills of Bioprocess Scientist DSP.
Support and implement new procedures and/or equipment in the OPS department in consultation with other owners and users.Revise and author SOPs and logbooks.Adhere to Patheon cGMP Quality Management System and the Patheon EH&S requirements.Complete corrective and preventive actions, contribute in deviation investigations and support the timely closure of deviation reports and change controls.Implement lean (OE) initiatives and continuous improvements.Contribute to the transfer and understanding of specific new technologies to DSP.Connect with suppliers about issues of technical nature.Minimum Requirements / Qualifications: Qualifications & Experience:Either experience in pharmaceutical industry OR tertiary education in science or engineering-based field (i.e.
biopharmaceuticals manufacture, biotechnology, process technology).
Good understanding of cGMP practices.
Skills & Attributes:Ability to work unsupervised.
Good communication, flexibility, reliability, and assertiveness.
Responsible and proactive.
Other Job Requirements:Your position may require you to be on shift or on call.
Should this be a requirement, there will be remuneration as per the Company's policy.
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.
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