Manufacturing Technician

Overview:

Tasked with overseeing the production of biologics, conducting operations in production facilities to facilitate downstream manufacturing in accordance with current Good Manufacturing Practices (cGMPs).

Responsibilities:

• Prepare instruments, conduct downstream purification processes, and perform clean room tasks adhering to cGMP standards under supervision.
• Execute procedures outlined in GMP documentation, including SOP/MBR, and promptly communicate with the internal team regarding floor activities, escalating issues to supervisors when necessary; Document deviations from SOP/MBR requirements.
• Participate in deviation investigations and the implementation of Corrective and Preventive Actions (CAPAs).
• Maintain cleanliness in the clean room as per cGMP requirements, including equipment surface cleaning, periodic cleaning, and changeover cleaning.
• Assist supply chain and Engineering teams with equipment validation, calibration, and maintenance.
• Utilize support systems such as LIMS as needed during GMP production.
• Perform job-specific tasks in compliance with Regulations, International Standards, and Policies.
• Promote and practice safe work habits, adhering to safety procedures and guidelines.

Requirements:

• High School Diploma/GED or College Degree
• Previous experience in the Pharmaceutical industry preferred
• Prior experience in bulk biologics cGMP manufacturing is advantageous.
• Experience working in a manufacturing environment
• Familiarity with TFF skids, centrifuges, chromatography columns and systems, and/or UF/DF systems preferred.
• Strong communication skills, teamwork abilities, and capacity to foster positive collaborations with internal stakeholders, vendors, and clients to achieve common goals effectively.
• Must demonstrate self-motivation, flexibility, organization, and attention to detail.

For California Applicants:

We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO) , and the California Fair Chance Act (CFCA).

This position is subject to a background check based on its job duties, which may include patient care, working with vulnerable populations, access to financial and confidential information, driving, working with heavy machinery, or working in a warehouse or laboratory environment. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.