Sr. Manager - API Peptide Maintenance Management

Job Title

Location

Job Summary

We are looking for an experienced Sr. Manager to lead our API Peptide Maintenance Management team. The successful candidate will be responsible for developing and implementing maintenance strategies to ensure optimal performance, reliability, and compliance of peptide manufacturing equipment and facilities.

Key Responsibilities:

• Develop and implement comprehensive maintenance management plans for peptide synthesis, purification, and lyophilization equipment.
• Lead and manage a team of maintenance personnel, providing guidance and training on peptide-specific maintenance practices.
• Collaborate with cross-functional teams (Peptide Synthesis, Purification, Quality, and Engineering) to identify and prioritize maintenance activities.
• Develop and manage maintenance budgets, ensuring cost-effective maintenance practices for peptide manufacturing equipment.
• Ensure compliance with regulatory requirements (cGMP, FDA, etc.) and internal quality standards for Equipment maintenance.
• Implement and manage preventive maintenance programs for Peptide & Supporting equipment, including scheduling, execution, and documentation.
• Conduct regular maintenance audits and risk assessments to identify areas for improvement in peptide maintenance.
• Develop and implement corrective actions to address peptide maintenance-related issues.
• Collaborate with external vendors and contractors to ensure effective maintenance support for all equipment.
• Develop and maintain maintenance-related documentation, including SOPs, procedures, and records for peptide and all supporting manufacturing equipment.

Requirements:

• Bachelor's degree in Mechanical, Chemical Engineering.
• Minimum 15-17 years of experience in maintenance management, in

  API peptide

  manufacturing environment.
• Proven experience in leading and managing maintenance teams, with a focus on peptide maintenance.
• Strong knowledge of cGMP, FDA regulations, and industry best practices for peptide manufacturing.
• Excellent communication, leadership, and Maintenance & project management skills.
• Ability to work in a fast-paced environment and prioritize multiple tasks.

Desirable:

• Master's degree in Mechanical, Chemical Engineering,
• Certification in maintenance management or a related field.
• Experience with computerized maintenance management systems (CMMS).
• Familiarity with lean manufacturing principles and Six Sigma methodologies.