Sr. Process Engineer

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Requirements:

• Bachelor’s degree in Engineering, regulatory affairs, or a related field.
• Minimum of 7-11 years of experience in pharmaceutical manufacturing and packaging.
• Deep understanding of cGMP, FDA, EMA, and USP guidelines.
• Proficiency with quality systems and compliance.
• Strong project management and leadership abilities.
• Excellent communication skills and detail-oriented.

Responsibilities:

• Maintain and enhance manufacturing and packaging quality systems to ensure compliance with FDA, EMA, and related regulations.
• Develop and improve standard operating procedures (SOPs) and work instructions related to manufacturing and packaging processes.
• Lead change management strategies for manufacturing and packaging.
• Manage and review equipment change requests to ensure timely and compliant updates.
• Collaborate with regulatory, quality, and manufacturing teams for effective execution.
• Plan and execute manufacturing and packaging projects from concept to implementation.
• Identify project risks and implement mitigation strategies.
• Drive continuous improvement initiatives in manufacturing and packaging processes.