Work Schedule
12 hr shift/days
Environmental Conditions
Able to lift 40 lbs.
without assistance, 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.).
Will work with hazardous/toxic materials.
Job Description
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:
Complete unit Operations in Media and Buffer Preparation suites as advised by the MBP Supervisor.
Key Responsibilities:
Provides meaningful accountability to the overall departmental responsibility for the production of biopharmaceutical solutions and process intermediates, including maintaining optimised operational areas.
Dispensing of raw materials, preparation of media and buffer solutions (multiple 1000 L batches per day), manifold preparation and autoclaving, filter integrity testing.
Works proactively to supply lead lean (OE) initiatives and continuous improvements.
Revises, assists in review, and writes documentation such as SOPs and ACFs.
Perform equipment testing, troubleshooting and complete validation protocols with developed skills of Bioprocess Scientist II.
Supports the implementation of new procedures and/or equipment in the OPS department in consultation with other owners and users, including support to changes (CRF).
Propose and implement Corrective and Preventive Actions and support the timely closure of Deviation Reports and Change Controls as well as writing Minor Deviation Reports.
A pro-active demeanor and personal initiative is encouraged to identify and overcome practical problems, propose possible solutions, and communicate to the responsible person.
Communicates with suppliers about issues of technical nature.
All activities should be performed independently within the department coherent with cGMP Quality System and the Patheon EH&S requirements.
Any reasonable additional tasks that might be required for day-to-day Operational activities.
Minimum Requirements/Qualifications:
Qualifications & Experience
Tertiary education in science or engineering based field (i.e.
biopharmaceutical manufacture, biotechnology, process technology) or relevant proven experience.
Very good knowledge and working in cGMP environment.
Specific knowledge of relevant process unit operations and quality systems.
Skills & Attributes
Strong organisational, scheduling and planning skills.
Ability to work unsupervised.
Good communication, flexibility, reliability and assertiveness.
Responsible and proactive.
We offer competitive compensation and benefits packages, along with opportunities for professional growth and development.
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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