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Biopharmaceutical Process Specialist
2 months ago
Thermo Fisher Scientific Inc. is a world leader in serving science, with a mission to enable our customers to make the world healthier, cleaner, and safer. We are seeking a Biopharmaceutical Process Specialist to join our team.
Job Summary:The successful candidate will be responsible for completing unit operations in Media and Buffer Preparation suites as advised by the MBP Supervisor. This includes dispensing of raw materials, preparation of media and buffer solutions, manifold preparation and autoclaving, filter integrity testing, and performing equipment testing, troubleshooting, and validation protocols.
Key Responsibilities:- Provide meaningful accountability to the overall departmental responsibility for the production of biopharmaceutical solutions and process intermediates.
- Work proactively to supply lead lean (OE) initiatives and continuous improvements.
- Revises, assists in review, and writes documentation such as SOPs and ACFs.
- Support the implementation of new procedures and/or equipment in the OPS department in consultation with other owners and users.
- Propose and implement Corrective and Preventive Actions and support the timely closure of Deviation Reports and Change Controls.
- Communicate with suppliers about issues of a technical nature.
- Perform all activities independently within the department coherent with cGMP Quality System and the Patheon EH&S requirements.
- Tertiary education in a science or engineering-based field (i.e. biopharmaceutical manufacture, biotechnology, process technology) or relevant proven experience.
- Very good knowledge and working experience in a cGMP environment.
- Specific knowledge of relevant process unit operations and quality systems.
- Strong organisational, scheduling, and planning skills.
- Ability to work unsupervised.
- Good communication, flexibility, reliability, and assertiveness.
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.
