Qualifications

• Bachelor's or Master's degree in Chemistry, Engineering, Life Sciences, or related field.
• Experience in analytical equipment qualification in GMP environments.
• In-depth knowledge of FDA regulations and GAMP 5 standards.
• Proficient in data integrity principles and manufacturing equipment qualification.
• Familiarity with electronic document systems and validation tools.

Responsibilities

• Act as the technical Subject Matter Expert (SME) for equipment qualification in a manufacturing context.
• Develop and implement qualification protocols in line with regulatory standards.
• Oversee lifecycle activities for equipment, including requalification and decommissioning.
• Ensure compliance with data integrity in computerized systems connected to analytical instruments.
• Work with cross-functional teams to establish qualification strategies for new equipment.
• Maintain links between user needs and qualification outputs.
• Lead change control assessments for equipment modifications or upgrades.
• Prepare for audits by providing qualification documentation and expert insights.
• Enhance qualification practices and documentation across global locations.

Benefits

• Collaborative work environment with cross-functional teams.
• Opportunities for professional growth and development in a reputable company.
• Global exposure to best practices in validation and qualification.
• A chance to drive continuous improvement initiatives.
• Work on cutting-edge technology related to medical devices.