Process/Maintenance Engineering Manager

The Process and Maintenance Engineering Manager is responsible for leading the site's engineering and maintenance functions to ensure optimal equipment reliability, regulatory compliance, and operational efficiency across all manufacturing and utility systems. This role oversees preventive and predictive maintenance programs, spare parts strategies, and continuous improvement initiatives to enhance equipment performance and reduce downtime.

The position also manages the Process Engineering team, driving process optimization, cost reduction, and technical problem-solving. Additionally, the manager ensures all engineering and maintenance activities comply with internal SOPs, GMP regulations, and corporate standards, including oversight of CAPAs, change controls, deviations, and documentation updates.

• Lead and develop the Process and Maintenance Engineering team, fostering technical expertise and continuous improvement culture.
• Design and sustain preventive and predictive maintenance programs, ensuring reliability and efficiency of manufacturing and utility systems.
• Drive process optimization projects to improve equipment performance, reduce costs, and enhance operational efficiency.
• Ensure compliance with GMP, FDA, and corporate standards in all engineering and maintenance activities.
• Oversee and coordinate CAPA, change control, deviations, and exception investigations related to engineering and maintenance operations.
• Develop, review, and approve SOPs, work instructions, and technical documentation for maintenance and engineering processes.
• Collaborate with Quality, Production, and Validation teams to ensure alignment on system ownership and improvement plans.
• Establish and monitor performance metrics and dashboards for maintenance effectiveness, reliability, and compliance.
• Provide leadership, coaching, and technical support to engineers, compliance specialists, and maintenance personnel.
• Support capital and expense planning through equipment condition assessments and reliability data analysis.
• Maintain engineering document control for equipment, utilities, and facilities.
• Ensure audit readiness and regulatory inspection support through robust documentation and compliance practices.
• Track and report compliance-related action items, including CAPA aging, change control cycle time, and PM completion rates.
• Lead training initiatives for engineering and maintenance teams to reinforce compliance and technical best practices.
  
  

• Bachelor's Degree in Engineering (Mechanical, Electrical, Industrial, or related field) required; Master's preferred.
• 8-10 years of experience in maintenance, reliability, or process engineering management within a pharmaceutical or regulated manufacturing environment.
• Strong knowledge of preventive and predictive maintenance strategies, reliability engineering principles, and process optimization.
• Experience with CMMS systems (Maximo preferred) and maintenance planning.
• Proven ability to lead CAPA, change control, and compliance documentation processes.
• Demonstrated success in leading technical teams and driving continuous improvement.
• Strong understanding of GMP, FDA, and ISO regulations.
• Excellent analytical, organizational, and communication skills.
• Proficient in Microsoft Office and Quality Management Systems (QMS).
  

All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.