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1000 Merck Sharp & Dohme LLC

Associate Specialist, Process Engineer - Oral Solid Dosage, Clinical Manufacturing (Onsite)

Job Description

Job Description Job Description:
The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey. This team works with non-sterile formulations, typically oral solid dosage (blending, roller compaction, encapsulation, tableting) including spray dried intermediates, liquid suspension/bottle fills, and autoinjector assembly. We are part of the research division, focusing on development and clinical deliveries in a GMP piloting facility supporting our Company's research division. The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an Associate Specialist
  • Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to enable flexibility and speed of our Company's pipeline.
This person will:
Lead on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products. Draft and execute GxP documentation including but not limited to batch records, equipment qualification and cleaning, change records and deviations. Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives. Foster culture of collaboration, learning and innovation.
Required Experience and Skills:
Experience executing GxP manufacturing in pilot plant environment. Experience of interest in supporting electronic batch records and MES systems. Knowledge and experience of drug product processing. Desire and willingness to learn and contribute through independent problem-solving. Experience in leading and supporting quality investigations and change management.
Education Minimum Requirements:
Associate's degree in chemical engineering, Chemistry, Pharmaceutical Sciences or related field with a minimum of 3 years relevant experience Bachelor's in chemical engineering, Chemistry, Pharmaceutical Sciences or related scientific field. Master's degree in chemical engineering, Chemistry, Pharmaceutical Sciences or related scientific field
Preferred Experience and Skills:
Knowledge of Investigational drug regulatory requirements Understanding of Clinical Supply Chain Operations Experience with Commissioning, Qualification and Validation Experience with spray dried intermediates and/or hot melt extrusion #EBRG #VETjobs #
FLEX Required Skills:
Control de calidad de fabricación, Control de Procesos, Cualificación de equipos, Cumplimiento GMP, Estándares de ingeniería, Estimación y planificación, Fabricación a escala, Impulso de la mejora continua, Optimización de Procesos, Producción ajustada, Trabajo en equipo, Validación
GMP 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 primary location for this posting is: USA
  • Nueva Jersey
  • Rahway Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $71,900.00
  • $113,200.
00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of 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 . Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the salary ranges for additional locations below. If the salary range is not listed for the location you are applying to, our Talent Acquisition team will provide further information to you relevant to your location. Additional location(s)
Compensation Information:
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 VISA Sponsorship:
No Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable Shift:
Not Indicated Valid Driving License:
No Hazardous Material(s):
Acetone, Iso-Propyl Alcohol Job Posting End Date:
11/6/2026
  • 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.

Benefits

  • Paid Time Off (PTO)
  • 401(k) Plans
  • Other Retirement and Savings
  • Health Insurance
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Total Score
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