Qualifications

• Bachelor's Degree in Engineering, Science, or a related technical field required.
• Consideration for an Associate's Degree with six years of relevant experience, or a High School Diploma with eight years of experience in a GMP regulated environment.
• Minimum of four years engineering or technical experience required, ideally in a GMP setting.
• cLEAN 1Star Certification is a must.
• Preferred knowledge of FDA regulations and compliance expectations.
• Experience in establishing networks for cross-organizational knowledge sharing is a plus.
• Familiarity with Process Control Systems and requirements documentation is preferred.
• Functional expertise in one or more operations is necessary.

Responsibilities

• Support daily operations through sharing process knowledge and making critical decisions.
• Drive the qualification and optimization of equipment and validation processes.
• Coach and mentor team members to enhance team capabilities.
• Conduct monitoring activities for key process parameters and track initiatives.
• Collaborate on interface identification with other processes and support systems.
• Facilitate coordination between site stakeholders and different teams.
• Gather knowledge transfer from other production sites to improve processes.
• Generate and implement improvement concepts based on operational needs.

Benefits

• Collaborative work environment that encourages knowledge sharing and professional growth.
• Opportunities for continuous improvement and career development.
• Training and mentoring support from experienced leaders.
• Potential for cross-organizational collaboration across production sites.
• Compliance with safety and environmental regulations in daily operations.