Associate Director, Engineering (Onsite)

Job Description The Formulation Laboratory and Experimentation (FLEx) Center in Rahway, New Jersey provides a launch pad for the early phase and commercial formulation development and GMP clinical supply manufacture of our Company's drug product pipeline. The FLEx Sterile Process Engineer at the Associate Director level will serve as a technical subject matter expert in process development, equipment and facility optimization, and new capabilities across the sterile development facility. They will collaborate closely with scientists and engineers from the research and manufacturing divisions in the development of a portfolio of sterile drug product formulations using the capabilities and facilities of the FLEx Center. They will be responsible for the technical mentorship and coordination of work for process engineering colleagues to develop robust and innovative drug product manufacturing processes. Close partnership with colleagues from Sterile Product Development, Quality, Regulatory Affairs, Engineering, and Analytical will be required to ensure effective process development in support of clinical development. The successful candidate will drive continuous improvement to realize the vision of the FLEx Center as a learning facility. They will serve as a role model for the culture of perpetual adherence to safety and compliance standards. A successful candidate should have extensive drug product process development experience, an affinity for hands-on problem solving, and excellent leadership and communication skills. The role is based in New Jersey and reports to the FLEx Sterile Process Engineering Lead in Pharmaceutical Operations & Clinical Supply.

Primary Responsibilities:

• Serve as a technical expert and mentor to a team of process engineers, tasked with becoming equipment and facility subject matter experts themselves.
• Provide trouble shooting support on the shop floor
• Drive internal capability development by evaluating new drug product technologies and deploying new technologies to develop pipeline assets
• Collaborate effectively within and across functional areas. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results.
• Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others
• Participate in external and internal audits, tours, and inspections
• Execute investigations, as needed
• Lead and drive a culture of continuous improvement across this facility

Education Minimum Requirement:

• Ph.

D. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with minimum 4 years of relevant experience or B.S. or M.S. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with minimum 7 years of relevant experience.

Required Experience and Skills:

• Knowledge of sterile drug product processing
• Experience with GMP manufacturing
• Effective interpersonal and communication skills, both verbal and written
• Excellent organizational skills to handle multiple priorities
• Track record of independent problem-solving

Preferred Experience and Skills:

• Experience with GMP facility operations
• Experience in leading and supporting quality investigations and change management
• Experience with quality systems
• Familiarity with US and EU GMP and Safety compliance regulations
• Experience with SAP, ERP or MES systems #PSCS Sterile2026 FLEx2026 #eligiblefor

ERP Required Skills:

Adaptabilidad, Adaptabilidad, Auditoría interna, Automatización de control de procesos, Comunicación, Comunicación interpersonal, Control de calidad de fabricación, Cumplimiento de seguridad, Cumplimiento GMP, Desarrollo clínico, Desarrollo de capacidades, Desarrollo de medicamentos, Desarrollo de procesos de producción, Desarrollo de procesos farmacéuticos, Elaboración de productos farmacéuticos, Enfocado en el cliente, Estimación y planificación, Farmacología, Fitoquímica, Formulación de productos, Ingeniería Química, Inmunoquímica, Liderazgo, Optimización de Procesos, Orientación técnica {+ 5 more}

Preferred Skills:

Current Employees apply HERE Current Contingent Workers apply HERE Solo para residentes en EE. UU. y

Puerto Rico:

Nuestra empresa está comprometida con la inclusión, velando para que las personas puedan participar en un proceso de contratación que muestre sus verdaderas capacidades. Haga clic aquí si necesita adaptaciones durante el proceso de solicitud o contratación. Somos un empleador que ofrece igualdad de oportunidades, comprometido con fomentar un lugar de trabajo inclusivo y diverso. Todos los solicitantes calificados recibirán consideración para el empleo sin distinción de raza, color, edad, religión, sexo, orientación sexual, identidad de género, origen nacional, estado de veterano protegido, o estado de discapacidad, u otras características protegidas legalmente aplicables. Para obtener más información sobre los derechos personales bajo las leyes de empleo de igualdad de oportunidades de los EE. UU., visite: EEOC Conozca sus derechos EEOC Suplemento GINA Transparencia de pago No discriminación Orgullosos de ser una empresa que adopta el valor de reunir a personas diversas, talentosas y comprometidas. La forma más rápida de lograr una innovación revolucionaria es cuando las ideas diversas se unen en un entorno inclusivo. Alentamos a nuestros colegas a desafiar respetuosamente el pensamiento de los demás y abordar los problemas de manera colectiva. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $142,400.00 - $224,100.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee's position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:

We will consider qualified applicants with arrest and conviction records for employment in compliance with the

San Francisco Fair Chance Ordinance Los Angeles Residents Only:

We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance Search Firm Representatives Please Read Carefully 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.

Employee Status:

Contrato indefinido

Relocation:

Domestic/International VISA Sponsorship:

No Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable Shift:

1st -

Day Valid Driving License:

No Hazardous Material(s): n/a

Job Posting End Date:

05/23/2026

• A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date.

Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Nuestra compañía es líder mundial de atención de la salud con una cartera diversificada de medicamentos con receta, vacunas y productos de salud animal. La diferencia entre potencial y logro radica en la chispa que alimenta la innovación y la creatividad; este es el espacio donde hemos codificado nuestro legado durante más de un siglo. Nuestro éxito está respaldado por la integridad ética, el impulso hacia adelante y una misión inspiradora para lograr nuevos hitos en la atención sanitaria global.