Job Overview
We are seeking a seasoned Formulation Equipment Specialist to provide technical leadership within our new Drug Product manufacturing facility. This key role will support the introduction, operation, and optimization of formulation equipment and processes, ensuring all systems are safe, compliant, and operating in line with industry standards.
Key Responsibilities:
* Technical Leadership: Provide strategic guidance for formulation equipment and processes within the Drug Product manufacturing area, driving operational excellence through structured problem-solving and continuous improvement initiatives.
* Equipment Management: Ensure all installed equipment is safe, effective, and compliant with applicable standards and engineering procedures, including vendor management, maintenance oversight, and spare part criticality assessments.
* Documentation and Reporting: Prepare and execute cGMP documentation, including risk assessments, testing protocols, and associated reports, ensuring accurate and timely submissions.
* Troubleshooting and Investigations: Troubleshoot equipment and process issues, collaborating with cross-functional teams to implement effective corrective and preventive actions, and lead technical investigations to identify root causes and implement CAPA.
* Process Optimization: Identify opportunities for process and equipment optimization, translating these into CI initiatives that drive efficiency and productivity gains.
Requirements:
* Education: Bachelor's degree in Engineering or a related field.
* Experience: Minimum 5 years of experience in formulation equipment management, with a focus on technical leadership and operational excellence.
* Skillset: Strong understanding of formulation equipment, process validation, and cGMP regulations; excellent communication and problem-solving skills; ability to work effectively in a team environment.
What We Offer:
* Competitive Compensation: Salary and benefits package that reflects your skills and experience.
* Career Development: Opportunities for growth and professional development in a dynamic and innovative organization.
* Collaborative Environment: Collaborative and inclusive work environment that fosters open communication and teamwork.