Technicien, opérations
Description du poste POCS – Rahway: Technician, Operations Level: O2 Job Family: Manuf/Operations Technician, Operations Timing: 3:30 PM to 12:00AM 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). 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. Attends and actively participates in safety, quality, and process improvement initiatives to enhance flexibility, efficiency, and compliance. 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 or higher Required Experience and Skills: Minimum of 2 years of relevant GMP Pharmaceutical 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, 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: At least 2 years GMP manufacturing/processing experience. 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, visual inspection of product in glass vials, 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. #MSJR #eligibleforERP #PSCS FLEx2026 Sterile2026 The salary range for this role is: $52,500 - $82,700 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: Bonnes pratiques de fabrication (BPF), Configuration d'équipement, Connaissances en informatique, Contrôle en cours de traitement, Environnements BPF, Fabrication stérile, Gestion des procédures opérationnelles standard, Habillage des salles blanches, Opérations GMP, Pensée analytique, Planification de la production, Processus de production, Résolution de problèmes, Tenue des comptes, Vaccinations Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Pour les résidents des États-Unis et de Porto Rico uniquement : Notre société s'engage en faveur de l'inclusion, en veillant à ce que les candidats puissent s'engager dans un processus d'embauche qui montre leurs véritables capacités. Veuillez cliquer ici si vous avez besoin d'un logement pendant le processus de candidature ou d'embauche. Nous sommes un employeur garantissant l'égalité des chances, engagé à favoriser un lieu de travail inclusif et diversifié. Tous les candidats qualifiés seront pris en considération pour un emploi sans distinction de race, de couleur, d'âge, de religion, de sexe, d'orientation sexuelle, d'identité de genre, d'origine nationale, de statut d'ancien combattant protégé ou de statut d'invalidité, ou d'autres caractéristiques légalement protégées applicables. Pour plus d'informations sur les droits personnels en vertu des lois américaines sur l'égalité des chances en matière d'emploi, visitez : EEOC Know Your Rights EEOC GINA Supplement Pay Transparency Nondiscrimination Nous sommes fiers d'être une entreprise qui encourage la valeur de réunissant des personnes diverses, talentueuses et engagées. Le moyen le plus rapide d'innover de manière révolutionnaire est lorsque diverses idées se rejoignent dans un environnement inclusif. Nous encourageons nos collègues à se défier respectueusement les uns les autres et à aborder les problèmes collectivement Learn more about your rights, including under California, Colorado and other US State Acts 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 Représentants d'entreprises de recherche, veuillez lire attentivement Merck & Co., Inc., Rahway, N.J., États-Unis, également connu sous le nom de Merck Sharp & Dohme LLC, Rahway, NJ, États-Unis, n’accepte pas d’aide non sollicitée des entreprises de recherche en ce qui concerne les occasions d’emploi. Tous les CV soumis par des entreprises de recherche à un employé de notre société sans un accord de recherche écrit valide pour ce poste seront considérés comme la propriété exclusive de notre Société. Aucun frais ne sera payé dans l'éventualité où un candidat serait embauché par notre Société suite à une recommandation d’agence si aucun accord préexistant n’est en place. Lorsque des accords d’agence sont en place, les introductions sont spécifiques au poste. N’essayez pas de nous joindre par téléphone ou par courriel. Statut de l'employé : Employé régulier Déménagement : Domestic Parrainage du VISA : No Exigences en matière de déplacement : No Travel Required Modalités de travail flexibles : Not Applicable Quart : 2nd - Evening Permis de conduire valide : No Matière(s) dangereuse(s) : n/a Job Posting End Date: 06/12/2026 *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. Merck est un chef de file mondial du domaine de la santé avec une gamme diversifiée de médicaments d’ordonnance, de vaccins et de produits de santé animale. La différence entre le potentiel et l’accomplissement réside dans l’étincelle qui stimule l’innovation et l’inventivité; il s’agit de l’espace où nous avons codifié notre héritage depuis plus d’un siècle. Notre succès est soutenu par l’intégrité éthique, l’évolution et une mission inspirante pour franchir de nouvelles étapes dans le domaine des soins de santé mondiaux. Apply To This Job