Sr. Manager, Engineering - CDMO

Sr. Manager, Engineering - CDMO

• Location:
  
  US-NC-Morrisville
• :
• Category:
  Engineering
• Position Type:
  Full-Time
• Working Hours:
  
  1st
  
  Shift: Monday
  - Friday, 8:00am - 5:00pm

At Alcami, we deliver reliable solutions that unlock the potential of transformative medicines from discovery to commercialization, through trusted partnership with our clients, recognized industry expertise and proven regulatory track record.

Are you interested in joining our team?

The Senior Manager, Engineering is responsible for the equipment and system performance of a cGMP manufacturing facility. The Sr. Engineering Manager leads, manages, and coaches engineering staff to ensure equipment and systems are designed, installed, and consistently perform as intended when needed. The Sr. Manager develops an engaged, high performing team that demonstrates Alcami core values with a culture of safety and quality.

The Sr. Manager of Engineering assists with developing strategies, processes, systems, procedures, and metrics to achieve a high level of equipment availability, reliability, and performance. The Sr. Manager monitors equipment work orders, change controls, qualification status, and readiness. Manages engineering processes associated with new product introductions. The Sr. Manager is responsible for developing and implementing strategies, methods, and procedures for new and existing equipment.

The Sr. Manager, Engineering oversees engineering support for multiple systems, processes, or areas. Develops subject matter experts in several areas. Applies advanced approaches to develop and implement strategies, technologies, or other major improvements. Directs, reviews, and approves engineering documents. Support monthly reports covering overall status, key issues, and performance KPI's. Responsible for directing, developing, and implementing the necessary controls and systems for the Site Engineering, and CAPEX project functions.

This role drives results and is responsible for successfully meeting client and departmental objectives in a timely manner. This position requires strong leadership behaviors, as well as expertise in the functional competencies included in this position.

• 100% on-site position.
• 1st
  
  Shift: Monday
  - Friday, 8:00am - 5:00pm.

• Provides leadership and direction to the Engineering team.
• Directs engineering and capital project activities for the site.
• Direct implementation of improvements to reduce failures and errors.
• Oversees multiple capital projects and operational improvement projects, DEVs, CAPAs, and/or Change Controls while ensuring their success in meeting their respective objectives.
• Comply with the general policy of the company.
• Promote a safe environment for work.
• Represent the Engineering activities during client audits and regulatory inspections.
• Ensures engineering procedures and systems are in a state of compliance and control.
• Establish and maintain a system of metrics and reporting to evaluate the effectiveness of engineering activities.
• Responsible for the employment, employee motivation, counseling, discipline, and changes in status of employees supervised. Responsible for team building, organizational development, training.
• Assists in development, strategy, planning, and execution related to drive improvements and achievement of objectives and goals.
• Maintains and broadcasts key metrics to management.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• Attracts, develops, and retains a high performing team to meet the current and evolving needs of the business through effective selection, training and development, coaching and mentoring and performance management.
• Participates in the hiring process of other…