Hybrid Director, Sterile Engineering

at MSD

• Job title: Director, Sterile Engineering
• Job type: Full Time
• Experience level: Lead
• Salary: $173,200 - $272,600 per year
• Degree requirement: Bachelor's Degree
• Location requirements: Hybrid, Rahway, United States

About the role

• Director of Sterile Engineering leading operations at FLEx Center and Sterile Liquids Pilot Plant. Ensuring compliance and innovation in sterile drug product manufacturing.

Responsibilities

• Oversee facility start-up /readiness for FLEx2 (GES capital project) and the daily operation of FLEx1 (facility in operation).
• This includes equipment engineering, automation, bio-sterile validation, maintenance & calibration, safety and compliance requirements to support development or GMP activities
• Oversee engineering activity and support for the Sterile Liquids Pilot Plant (WP17 SLP)
• Manage, develop, and grow a team of facility-facing engineers
• Provide trouble-shooting support on the shop floor
• Support internal capability development by evaluating and deploying innovative sterile manufacturing technologies to support new product development, both automated and non-automated
• Collaborate effectively within and across functional areas and possess advanced knowledge or experience in specialized engineering areas.
• Develop and lead Commissioning, Qualification & Validation activities (CQV)
• Participate in external and internal audits, tours, and inspections
• Ensure closure of investigations, as needed
• Establish and manage expense and capital projects, including expenditures via financial budgets and forecasts associated with the FLEx Center and the SLP
• Maintain facility and equipment systems in a state of permanent inspection readiness
• Recruit and develop staff, through objective setting, rewards and recognition, stretch leadership and/or technical assignments, and learning opportunities that broaden experience
• Sponsor and drive a culture of continuous improvement across these facilities

Requirements

• Bachelor's degree in Engineering, Pharmaceutical Sciences or related scientific field with a minimum of 10 years of relevant experience.
• Knowledge of and experience supporting sterile Drug Product manufacturing, including the use of advanced product filling and formulation equipment, application of isolators and advanced robotics
• Sterile engineering experience in a GMP clinical or commercial manufacturing environment
• Effective interpersonal and communication skills, both verbal and written
• Excellent organizational skills to manage multiple priorities
• History of independent problem-solving
• Experience with leading complex teams / matrix management

Benefits

• medical, dental, vision healthcare and other insurance benefits (for employee and family)
• retirement benefits, including 401(k)
• paid holidays
• vacation
• compassionate and sick days