Sr. Specialist, Engineering (Onsite)

Merck•Rahway, NJ

6h•$117,000 - $184,200•Onsite

About The Position

The Formulation, Laboratory, and Experimentation (FLEx) Center in Rahway, New Jersey, features a cutting-edge sterile drug product cGMP clinical supply manufacturing facility, known as FLEx Sterile, which is currently in the operational startup phase. The FLEx Sterile facility is poised to play a pivotal role in the long-term success of delivering our clinical pipeline to patients worldwide, encompassing a range of product modalities, including sterile small molecules, biologics, vaccines, and antibody-drug conjugates (ADCs). We are seeking a Sterile Operations Senior Engineer to serve as a key Senior Specialist in the FLEx Sterile Expansion Project, which is under construction activities. This expansion project aims to more than double the capacity of the existing FLEx Sterile Facility by adding a second clinical filling/lyophilization suite, a formulation suite, and a sterile supply suite, along with various supporting infrastructure and utilities. As construction of the expansion project continues, the selected candidate will lead operational readiness workstreams within the FLEx Sterile Expansion Project. They will leverage their relevant experience to contribute to equipment and facility design, system commissioning and qualification, and other critical activities necessary for facility startup. This role presents an exciting opportunity to collaborate with automation, digital and IT teams, equipment vendors, operations, global engineering and other stakeholders. Together, you will drive the design aspects, conduct risk assessments, engage in strategic planning, and ensure the successful execution of the project C&Q and startup phases of a new aseptic drug product filling facility. When operations commence, this individual will partner closely with the Formulators, Engineers, Quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable flexibility and speed of our Company's sterile pipeline.

Requirements

Bachelor's degree in Engineering, Science, Operations Management or equivalent with a minimum of 5 years of relevant experience.
Master’s degree with a minimum of 3 years of relevant experience
Manufacturing and GMP expertise: Experience in sterile drug product manufacturing, aseptic technique, quality systems, GMP/clinical supply operations, and investigational drug requirements.
Technical and equipment skills: Ability to operate, set up, adjust, and troubleshoot complex equipment, including robotics, automated systems, and packaging/assembling machinery.
Documentation and compliance: Strong documentation skills, with experience preparing SOPs and GxP documents, supporting investigations, change management, and Commissioning/Qualification/Validation.
Problem-solving and teamwork: Strong attention to detail, effective communication, and the ability to collaborate in a manufacturing environment.
Data and digital tools: Proficiency with data analysis and organization tools such as MS Access, Excel, Minitab, Power BI, and R Shiny.
Startup and continuous improvement: Experience in new GMP facility startup and knowledge of Lean principles.
Analytical Testing
Detail-Oriented
Equipment Qualification
Good Manufacturing Practices (GMP)
Process Hazard Analysis (PHA)
Process Optimization
Root Cause Analysis (RCA)
Strategic Thinking
Technical Leadership
Technical Problem-Solving

Nice To Haves

Automation
Continuous Improvement
Process Engineering

Responsibilities

Collaborate closely with stakeholders to gain insights into equipment and facility design, maintenance, troubleshooting, operational excellence, financial and capital management, team building, process sciences, technical writing, and networking
Operate state-of-the-art aseptic drug product formulation, filling, and lyophilization equipment throughout the manufacturing cycle. Perform aseptic manipulations within Grade A barrier isolation systems.
Manage individual project assignments and aid in facility and process equipment innovation.
Perform manual and/or automated operations, general maintenance, troubleshooting and support functions
Participate in operational readiness planning and documentation by developing and maintaining SOPs, work instructions, batch records, training curricula, process flows, job aids, and visual management tools to support compliant execution and go-live readiness.
Identify and addresses compliance, environmental, safety, and process deviations as appropriate while notifying appropriate personnel
Demonstrate safe work habits and maintain a safe work environment. Comprehend and comply with all safety and company policies and procedures.
Attend training classes, workshops, meetings, etc., as needed to improve job skills and product-related procedures.
Lead the planning, execution, and value realization of digital tools developed to drive rapid insights on the production process for troubleshooting and predictive analytics
Lead training, readiness assessments, and continuous improvement through onboarding programs, dry runs, simulations, issue tracking, and escalation planning to ensure personnel and processes are fully prepared before GMP Manufacturing.