Sr. Technician, Shared Services Operations (Onsite)

Descripción del trabajo POCS -

Rahway:

Sr.

Technician, Operations Level:

O3

Job Family:

Manuf/Operations Senior Technician, Operations Pharmaceutical Operations and Clinical Supply is seeking highly motivated individuals for R D Operations roles in our Rahway, NJ, Formulation, Laboratory, and Experimentation (FLEx) Center to support drug product development and GMP clinical supply of sterile dosage forms. Positions will support development and clinical manufacturing and supply, as part of the FLEx-Sterile team, specifically in Manufacturing Shared Services which supports sterile supply, aseptic formulation and visual inspection. This position will be responsible for hands-on processing activities that include equipment assembly and disassembly, sterile processing, inventory management, open aseptic formulation in an isolator and closed formulation activities in a Grade C environment, and manual visual inspection of filled units (i.e. vials or syringes). There is also opportunity to cross-train in other areas, such as filling. These individuals are expected to partner with and support formulation development colleagues in further understanding and knowledge capture of processes, which could include providing feedback on product and process development. These roles require adherence to GMP procedures, strong attention to detail in completing GMP documentation, proficiency in electronic systems, and participation in continuous improvement projects. Positions may also support commissioning, qualification, and demonstration of new equipment and technologies. Successful candidates will collaborate closely with team members and partner groups including formulators, engineers, Quality, Safety, and Facilities management to drive overall success and performance of the area and clinical pipeline.

Key Responsibilities:

Assembly:

Able to read, understand, and follow drawings to assemble sterile equipment to utilize in clinical development and manufacturing processes.

Sterilization Processes:

Operate and maintain cleaning and sterilization equipment, including parts washers, dry heat ovens, and autoclaves.

Supply Management:

Receive, inspect, and store sterile supplies and equipment, ensuring proper inventory levels and organization within the sterile supply area.

Sterile Formulation:

Prepare and formulate sterile products according to established protocols and batch records, ensuring accuracy and compliance with GMP standards. Able to perform closed formulation activities as well as open aseptic activities inside a Grade A isolator. Experience with operating isolator machines and/or Grade A aseptic experience is required.

Visual Inspection:

Perform visual inspections of products and components to identify defects, inconsistencies, and non-conformities. Individual should be detailed and organized, and able to manage a large quantity of units. Attention to

Detail:

Maintain meticulous records of formulation processes, including ingredient quantities, equipment used, and environmental conditions.

GMP Compliance:

Follow all GMP guidelines and standard operating procedures (SOPs) to ensure the quality and safety of clinical production lots. Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying management.

Batch Adaptability:

Quickly adapt to changes in batch procedures and production schedules, demonstrating flexibility and problem-solving skills.

Cleanroom Environment:

Able to gown and work in Grade C conditions, maintaining good aseptic cleanroom behaviors

Documentation:

Maintain accurate records of sterilization processes, inventory levels, and equipment logs in an electronic system. Knowledge of PAS-X is preferable.

Collaboration:

Able to communicate clearly with team and work closely with other teams to ensure on time delivery of supplies.

Training and Compliance:

Assist in training new staff on sterile supply procedures and protocols, ensuring adherence to GMP standards.

Leadership:

Able to identify and escalate issues, perform basic troubleshooting, and capturing learnings to improve systems and processes. Organizes and prioritizes own work to meet shop floor priorities and identifies discrepancies in advance. Also attends and actively participates in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance.

Schedule Adherence:

Understands schedule adherence impact and communicates risk. Maintains a continuous improvement mindset and implements initiates to increase efficiency or reduce risk to schedule adherence.

Compliance:

Identifies and addresses compliance, environmental, safety, and process deviations as appropriate while notifying management. Able to redline SOPS for continuous improvement. Supports investigations and implementation of corrective/preventative actions. Positions are based in Rahway, NJ and 100% on-site.

Education Minimum Requirements:

High School Diploma/GED, with at least 5 years in pharmaceutical manufacturing or processing OR Associates Degree in Science/Engineering related field with at least 3 years in pharmaceutical manufacturing OR Bachelors Degree in Engineering Technology or related field

Required Experience and Skills:

Relevant GMP Pharmaceutical experience, or equivalent (e.g. chemical, nuclear, military experience). Demonstrated written and verbal communication skills. Proficiency in computer systems and applications including but not limited to: Microsoft Office (Word, Excel and Outlook), Equipment HMI use, MODA, PAS-X, SAP, Calibration/Maintenance Database Systems. Good eyesight to perform detailed inspections Must be willing and able to lift 50 lbs, bend, stoop, squat, crawl, twist, climb ladders, and don & wear cleanroom protective gowning including respirators. Demonstrated ability to work and communicate both independently and as a part of a team. Flexibility working overtime is a requirement in manufacturing

Preferred Experience and Skills:

Familiarity with regulatory requirements and Good Documentation Practices (GDP). Experience with some of the following: highly complex and state of the art equipment, isolators, containment technology, aseptic filling using automated machinery, sterile manufacturing, SAP or other ERP systems. Associates Degree in science or related field. BioWork Certificate (working in an FDA or similar regulated industry). Experience with automated systems (MES, SAP, or similar). Demonstrated troubleshooting / problem-solving skills. Demonstrated ability to identify and initiate process improvements. First and second shift openings available #MSJR #eligibleforERP #PSCS FLEx2026 Sterile2026 The salary range for this role is: $70,300 - $110,700 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

Required Skills:

Alfabetización informática, Análisis de datos, Buenas prácticas de fabricación (BPF), Control de calidad de fabricación, Cumplimiento normativo, Desarrollo de procesos farmacéuticos, Elaboración de productos farmacéuticos, Normas de la FDA, Operaciones CNC, Planificación de Producción, Registros maestro de lotes, Selección de material, Técnicas de laboratorio, Trabajo de turnos, Trabajo en equipo

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".

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 Compañía de selección de personal, lea cuidadosamente‭ Merck & Co., Inc., Rahway, Nueva Jersey, EE. UU., también conocido como Merck Sharp & Dohme LLC, Rahway, Nueva Jersey, EE. UU. no acepta la asistencia no solicitada de las compañías de búsqueda de oportunidades de empleo. Todos los CV/currículums enviados por compañías de búsqueda a cualquier empleado de nuestra compañía sin un acuerdo por escrito válido de búsqueda para este puesto se considerarán propiedad exclusiva de nuestra compañía. No se pagará una cuota en caso de que un candidato sea contratado por nuestra compañía como resultado de la referencia de una agencia donde no haya un contrato preexistente válido. Cuando haya acuerdos de agencia válidos, las introducciones para este puesto son específicas. No llame ni envíe correos electrónicos.

Estado del empleado:

Contrato indefinido Reubicación: Domestic Patrocinio del visado: No Requisitos de viajes: 10% Acuerdos de trabajo flexible:

Not Applicable Turno:

1st - Day, 2nd - Evening Licencia de conducir válida: No Materiales peligrosos: n/a

Job Posting End Date:

04/23/2026 •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.