Sr. Specialist, Compliance/Engineering - Oral Solid Dosage (Onsite)

Job Description Position Summary The Senior Engineer (2nd Shift) in our Company's Research Labs (Pharm Ops Engineering) provides engineering and compliance support for the FLEx (Formulation, Laboratory & Experimentation) Center in Rahway, NJ. This role supports non‑sterile process equipment and utilities used in the manufacture of oral solid dosage (OSD) products across clinical, developmental, and commercial programs. The position operates with minimal supervision and serves as a key technical and compliance resource during second‑shift operations. Education Bachelor's degree in engineering with a minimum of 5 years of experience supporting pharmaceutical manufacturing operations for oral solid dosage (OSD) formats Required Experience and Skills Demonstrated commissioning and qualification experience supporting GMP manufacturing equipment in regulated environments Hands-on familiarity with OSD process equipment and operations, including granulation, milling, blending, drying, tablet compression and coating, and encapsulation Strong technical troubleshooting capability across mechanical, electrical, and automation systems Working knowledge of Quality systems, cGMP requirements, Good Documentation Practices (GDocP), and applicable Safety and Environmental policies and procedures Experience performing root cause analysis and supporting technical investigations in a manufacturing environment Familiarity with

CMMS/CCMS

platforms and validation documentation tools (e.g., Kneat) Strong organizational, time‑management, and communication skills with the ability to manage multiple priorities independently while collaborating effectively across cross‑functional teams Proficient with standard business and documentation software tools Key Responsibilities Independently provide second‑shift engineering support for OSD process equipment and associated utilities within a GMP manufacturing environment, operating with minimal supervision Develop and provide shift-change notes to ensure seamless support to the 1st shift team. Act as the secondary technical escalation point by reviewing procedures, wiring diagrams, equipment drawings, vendor manuals, and calibration/maintenance records to diagnose and resolve issues. Support troubleshooting of equipment and process issues, and implement effective corrective actions in collaboration with Operations, Process Engineering, Quality, and site technical teams Apply engineering principles and OSD process knowledge to support routine manufacturing activities, deviation response, and investigation efforts Provide Quality Engineering support to ensure facilities, utilities, and equipment remain compliant, qualified, and fit for GMP clinical, developmental, and commercial operations Adhere to all applicable safety requirements Author, review, and maintain GMP documentation, including procedures, IQ/OQ protocols, qualification reports, and engineering drawings, in accordance with site and regulatory requirements Execute commissioning, qualification, and decommissioning activities in alignment with approved protocols, change controls, and site standards #eligibleforERP #PSCS FLEx2026

Required Skills:

Adaptabilidad, Adaptabilidad, Análisis de causa raíz (ACR), Análisis de datos, Análisis de riesgo del proceso (PHA), Arquitectura de proceso, Buenas prácticas de fabricación (BPF), Cualificación de equipos, Cumplimiento GMP, Diseño del proceso, Documentación de software, Elaboración de productos farmacéuticos, Gestión de la desviación, Ingeniería de calidad, Ingeniería de proceso, Liderazgo técnico, Operaciones de fabricación, Optimización de Procesos, Orientado al detalle, Pensamiento estratégico, Pruebas analíticas, Redacción técnica, Resolución de problemas de equipos, Resolución de problemas técnicos, Revisión de protocolo {+ 2 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 U.S. Hybrid Work Model Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.

This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote". The salary range for this role is $117,000.00 - $184,200.00 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 VISA Sponsorship:

No Travel Requirements:

No Travel Required Flexible Work Arrangements:

Not Applicable Shift:

2nd -

Evening Valid Driving License:

No Hazardous Material(s): n/a

Job Posting End Date:

05/11/2026 •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.