The Formulation, Laboratory, and Experimentation (FLEx) Center is a new multi-modality (small molecule, biologics, vaccine) Drug Product development and Good Manufacturing Practice (GMP) clinical supply manufacturing facility in Rahway, New Jersey.

The Sterile Process Engineer role at the Senior Specialist level will leverage the individual’s leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization.

This role will directly support the pipeline’s most technically complex formulations and process development through process tech transfers, scale-up activities, quality investigations, change management, and authoring GMP standard operating procedures and protocols in support of sterile clinical drug product operations. This individual will collaborate closely with the development scientists, engineers, operations, quality representatives, and other team members to ensure the quality of the clinical supplies, the scientific rigor of the processes, and ultimately to enable the flexibility and speed of our Company’s pipeline. The role is, on-site, based in New Jersey and reports to the Sterile Process Engineering Lead of the FLEx GMP facility within Pharmaceutical Operations and Device Development (PSDD)., AutoCAD Visionary Innovation 3D Modeling Shop Drawing Communication Rhinoceros 3D Exhibit Design SolidWorks (CAD) Technical Drawing Parametric Modeling Artificial Intelligence Technical Documentation Engineering Documentation Fusion 360 (CAD Software) Engineering Design Process +0 Aseptic Technician- 2nd Shift Actalent

Fairfield, NJ*On-Site

Chemistry Operations Leadership Innovation Compassion Scale (Map) Supply Chain Adaptability Communication Data Analysis Investigation Process Design Pharmaceuticals Detail Oriented Clinical Trials Problem Solving Small Molecules Telephone Skills Change Management Biopharmaceuticals Strategic Thinking Analytical Testing Sterile Processing Root Cause Analysis Process Development Medicinal Chemistry Contingent Workforce Process Optimization Technical Leadership Willingness To Learn Chemical Engineering Deviation Management Organizational Skills New Product Development Pharmaceutical Sciences Process Hazard Analysis Medical Supply Management Standard Operating Procedure Good Manufacturing Practices Sterile Techniques And Procedures, + Bachelor’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 5 years relevant experience

• Master’s degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years of relevant experience, or a
• PhD degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of years of relevant experience.

Required Experience and Skills: *

• Excellent enterprise leadership skill demonstration
• Excellent interpersonal and communication skills, both verbal and written.
• Experience in leading quality investigations and change management.
• Familiarity with United States and European Union GMP and Safety compliance regulations.
• Ability to convert new drug product attributes and process needs to an executable series of steps and procedures to enable acceptable product manufacture.
• Ability to prepare Standard Operating Procedures (SOP) and current GXP documents.
• Experience with quality systems.
• Excellent organizational skills.
• Desire and willingness to learn, contribute and lead.
• Track-record of independent problem-solving.

Preferred Experience and Skills: *

• Experience with sterile GMP facility startup.
• Knowledge of Investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.
• Expertise in drug product aseptic processing, equipment, and sterile technique.

eligibleforERP, Adaptability, Adaptability, Analytical Testing, Change Management, Chemical Engineering, Clinical Trials Operations, Data Analysis, Detail-Oriented, Deviation Management, Equipment Qualification, GMP Compliance, Good Manufacturing Practices (GMP), Medical Supply Management, Medicinal Chemistry, Pharmaceutical Sciences, Process Design, Process Hazard Analysis (PHA), Process Optimization, Root Cause Analysis (RCA), Standard Operating Procedure (SOP), Standard Operating Procedure (SOP) Development, Sterile Procedures, Strategic Thinking, Technical Leadership, Technical Problem-Solving {+ 1 more}, Asepsis

Visionary Operations Innovation Punctuality Disinfecting Biotechnology Sterilization Pharmaceuticals Detail Oriented Medical Devices Computer Literacy Strong Work Ethic Aseptic Processing Sterile Processing Workflow Management Process Architecture Artificial Intelligence Engineering Design Process Standard Operating Procedure Good Manufacturing Practices

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively.

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The salary range for this role is $117,000.00 - $184,200.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.