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Biopharmaceutical Process Specialist
2 months ago
Thermo Fisher Scientific Inc. is a leading global biotechnology company that enables our customers to make the world Healthier, Cleaner and Safer. We are seeking a highly skilled Biopharmaceutical Process Specialist to join our team in a dynamic and fast-paced environment.
Key Responsibilities:- Develop and implement process improvements to optimize operational areas, ensuring the production of high-quality biopharmaceutical solutions and process intermediates.
- Collaborate with cross-functional teams to supply lead lean initiatives and continuous improvements, revising and writing documentation such as Standard Operating Procedures (SOPs) and Automated Control Files (ACFs).
- Perform equipment testing, troubleshooting, and validation protocols, utilizing developed skills as a Bioprocess Scientist II.
- Support the implementation of new procedures and/or equipment in the Operations department, consulting with other owners and users, including support to changes (Corrective and Preventive Actions).
- 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.
- Communicate with suppliers regarding technical issues.
- Perform all activities independently within the department, adhering to cGMP Quality System and Patheon EH&S requirements.
- Assist with other operational activities as required.
Qualifications & Experience
- Tertiary education in a science or engineering-based field (e.g., biopharmaceutical manufacture, biotechnology, process technology) or relevant proven experience.
- Excellent knowledge and working experience in a cGMP environment.
- Specific knowledge of relevant process unit operations and quality systems.
- Strong organizational, scheduling, and planning skills.
- Ability to work independently.
- Excellent 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.