Engineering Support Technician

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 Specialist level will leverage the individual's leadership, technical, and communication skillsets to drive the success of our clinical manufacturing facility and organization. As the facility is nearing the completion of its' Process Simulation execution, the selected candidate will lead and contribute to the launch and regulatory certification of the facility startup and operational readiness activities. This role will have extensive leadership potential as the first representative of our team on second shift.

Once the facility is operational, this role will support the pipeline's most technically complex formulations and process development through process tech transfer, 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 formulation scientists, engineers, operations staff, 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)., Florham Park, NJ*Remote Auditing Operations Communication Report Writing Detail Oriented Network Routing SolidWorks (CAD) Document Control Change Management Bill Of Materials Business Valuation Workflow Management Root Cause Analysis Engineering Support Release Engineering Organizational Skills Full Stack Development Contract Manufacturing Change Control Process Artificial Intelligence Business Transformation Engineering Change Order Engineering Documentation Critical Illness Insurance Document Management Systems Product Lifecycle Management Continuous Improvement Process

Teamwork Vaccines Chemistry Operations Leadership Innovation Compassion Supply Chain Adaptability Communication Investigation Pharmaceuticals Problem Solving Small Molecules Telephone Skills Change Management Technical Writing Biopharmaceuticals Process Simulation Sterile Processing Process Development Process Engineering Facility Operations Contingent Workforce Process Optimization Willingness To Learn Chemical Engineering Organizational Skills New Product Development Mammalian Cell Cultures Pharmaceutical Sciences Standard Operating Procedure Good Manufacturing Practices, + Bachelor's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 3 years relevant experience

• Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field.

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 operations.
• Knowledge of Investigational drug regulatory requirements.
• Understanding of Clinical Supply Chain Operations.

#eligibleforERP, Adaptability, cGMP Guidelines, Electronic Batch Records, Laboratory Experiments, Mammalian Cell Culture, Personal Initiative, Pilot Plant Operations, Process Engineering, Process Optimization, Product Formulation, Standard Operating Procedure (SOP) Writing, Sterile Manufacturing, Teamwork, Technical Writing, Troubleshooting

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.

Learn more about your rights, including under California, Colorado and other US State Acts

The salary range for this role is $87,300.00 - $137,400.00

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.