- Assist in preparation of solutions and buffers for the manufacturing process.
- Complies with all pertinent SOPs and/ or master batch record following GMP guidance.
- Must have a strong working knowledge and complies with cGMP guidance as applicable.
- Must have experience working with in ISO 8, 7 environments.
- Strong background in Single-Use technology.
- Familiar with Downstream manufacturing, depth filtration, TFF, and Final Fill.
- Assist with production process steps as needed.
- Assist with the cleaning/ sanitizing of manufacturing vessels, equipment and other process related items.
- Assist with cleaning/ sanitizing of rooms and fixed equipment in the aseptic production area.
- Must be able to write SOPs and other GxP documents.
- Must be able to assist/ write and implement deviations, investigations, and CAPAs
- Daily visual and physical checks/ calibrations of all in-process equipment.
- Review and document data with accuracy.
- Must be able to setup and execute projects independently.
- Must be able to troubleshoot and maintain process equipment.
- Must display leadership characteristics.
- Must have strong communication skills internal and external to the department.
- Must be able to work well with a team.
- Must be able to follow written and/or verbal direction.
- Associate's degree or equivalent professional experience. Bachelor's degree a plus.
- 8-10 years of relevant work experience in Pharma company.
- High attention to details.
- Proven documentation skills.
- Dedication to production quality.
- Experience with production planning.
- Family with equipment calibration techniques.
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Manufacturing Technician - South Plainfield, United States - Kashiv BioSciences LLC
Description
Kashiv is one of a few domestic companies to manufacture and launch a biosimilar in the United States. As a fully integrated biopharmaceutical company, Kashiv BioSciences offers advanced drug delivery technologies, biosimilars, and specialty pharmaceutical products to strategic partners, physicians, and patients worldwide.
The Manufacturing Technician provides daily support for all cGMP manufacturing activities, including but not limited to the preparation of all solutions, buffers and all activities associated with an aseptic production area, such as room and equipment cleaning and moving equipment as needed. Follow cGMP guidelines at all times. Takes responsibility to be properly trained and helps to ensure that all training records are kept up-to-date.
Key Duties & Responsibilities
Position Requirements and Qualifications
Education:
Experience:
Work Environment & Physical Demands:
General work environment and physical demands as required to successfully perform the essential functions of this job. Ability to work flexible hours as needed. Ability to work under pressure and meet deadlines. Some travel may be involved.
Supervisory Responsibility, if any: No
This position description is not a complete list of all responsibilities, duties or skills required for the job and is subject to review and change at any time, with or without notice, in accordance with the needs of the organization.
Kashiv Biosciences, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Kashiv Biosciences, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities.
