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職務說明 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: GMP 作業, GMP 環境, 優良製造作業規範 (GMP), 分析思維, 問題解決, 標準作業程序 (SOP) 管理, 無塵室穿衣, 無菌製造, 生產排程, 疫苗接種, 製程中管制 (IPC), 製造工藝, 記錄保存, 設備設置, 電腦素養 Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE 如果您在申請期間需要住宿，請寫電子郵件到 [email protected] 更多根據公平就業機會中有關個人權利的資訊，請造訪： 公平就業機會委員會海報 公平就業機會委員會 GINA 補充 OFCCP 公平就業機會補充 我們是公平機會雇主，少數團體/女性/殘障人士/退伍軍人 – 以公司展現的多元化局面為榮。 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 人才招聘公司代表，請仔細閱讀 Merck & Co., Inc., Rahway, NJ, USA（也稱為 Merck Sharp & Dohme LLC, Rahway, NJ, USA）不接受獵頭公司主動提供的就業機會幫助。人才招聘公司提交給本公司任何員工的所有專業履歷/簡歷，若無對此職位的有效書面招聘協議，將視為本公司專有。 若本公司聘僱由某個中介機構推薦的人選，在缺乏既有協議的情況下，將不支付介紹費給該機構。在具備中介協議的情況下，介紹費為針對具體職位。請勿打電話或發送電子郵件。 員工狀況： 定期 外派： Domestic 簽證贊助： No 出差要求： No Travel Required 彈性工作安排： Not Applicable 輪班時段： 2nd - Evening 有效駕照： No 危險品： 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. 本公司是全球醫療保健龍頭，在處方藥、疫苗和動物健康產品的多元產品組合。在可能性和成就之間的差異在於點燃創新和創造力的火花；我們在這個空間裡編撰我們的傳奇已經超過一個世紀。我們有道德誠信、前進動力，以及令人鼓舞的使命為背書，就能達成全球醫療保健的嶄新里程碑。 Apply To This Job