Job Description

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.

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