Merck · 4 hours ago
Director, Sterile Engineering
Rahway, NJ
Full-time
Onsite
Director/Executive
$173K/yr - $273K/yr
10+ years expMerck is a leading pharmaceutical company, and they are seeking a Director of Sterile Engineering to oversee the FLEx Center and provide engineering support for the Sterile Liquids Pilot Plant. The role involves ensuring compliance and operational readiness while fostering a culture of continuous improvement and collaboration across various teams.
BiotechnologyHealth CareMedicalPharmaceutical
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. The desired individual is someone who will bring deep subject matter expertise to the position as well as have the discipline to drive results
Maintain awareness of relevant new and current sterile Drug Product manufacturing technologies, capabilities, and effectively share this knowledge with others. 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
Qualification
Required
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
Preferred
Experience with GMP facility engineering, including utilities and infrastructure
Experience with leading organizational change
Experience in leading and supporting quality investigations and change management
Experience with a GMP Quality Management System (QMS)
Familiarity with US and EU GMP and Safety compliance regulations
Experience with CMMS & CCMS systems and Reliability Based Engineering methodology
Familiarity with computer systems and applications including but not limited to: Programmable Logic Controllers (PLCs), Calibration/Maintenance Database Systems
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
Company
Merck
Merck is a biopharmaceutical company that offers medicines and vaccines for various diseases.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$5.59MKey Investors
Private Capital Advisors"Gavi, the Vaccine Alliance"
2018-11-25Post Ipo Equity· $0.59M
2016-01-21Series Unknown· $5M
1980-12-19IPO
Leadership Team
Betty Larson
Executive Vice President and Chief Human Resources Officer
Dean Li
Executive Vice President and President, Merck Research Laboratories
Recent News
2026-02-05
Genetic Engineering News
2026-02-05
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