MSD

Director, Sterile Engineering

MSD

full-time

Posted on:

Location Type: Hybrid

Location: Rahway • New Jersey • Pennsylvania • United States

Visit company website

Explore more

✨ AI Apply
Apply

Salary

💰 $173,200 - $272,600 per year

Job Level

Lead

About the role

  • 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
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
equipment engineeringautomationbio-sterile validationmaintenancecalibrationCommissioningQualificationValidationadvanced product filling equipmentadvanced robotics
Soft Skills
interpersonal skillscommunication skillsorganizational skillsproblem-solvingteam leadershipmatrix managementcollaborationcontinuous improvement
Certifications
Bachelor's degree in EngineeringBachelor's degree in Pharmaceutical Sciences