Manufacturing Specialist

Responsibilities:

• Execute biopharmaceutical manufacturing processes with precision, ensuring compliance with cGMP regulations and industry standards.
• Operate, monitor, and troubleshoot production equipment to maintain efficient workflows and minimize downtime.
• Prepare, review, and maintain detailed manufacturing documentation, including batch records, SOPs, and deviation reports.
• Analyze and resolve equipment and process challenges, implementing corrective actions as needed.
• Collaborate closely with cross-functional teams such as Engineering, R&D, Quality Assurance, and Supply Chain to support seamless operations.
• Participate in the design, validation, and implementation of new manufacturing processes and equipment.
• Drive continuous improvement initiatives to enhance process efficiency, reduce waste, and maintain product quality.
• Ensure adherence to all safety protocols, maintaining a clean and organized work environment.
• Provide training and support to manufacturing staff to ensure compliance and knowledge of best practices.

Qualifications:

• High school diploma or equivalent.
• 2+ years of experience in a regulated environment.
• Knowledge of GMP regulations and production equipment.
• Strong problem-solving, organizational, and communication skills.
• Ability to collaborate effectively with cross-functional teams.
• Detail-oriented with a focus on quality and compliance.