Operations Expert

2 weeks ago


Rahway, New Jersey, United States MSD Malaysia Full time
Senior Operations Specialist - Facilities and Project Lead Job Description
The West Point campus is a significant vaccine manufacturing site with a large workforce.

This facility is dedicated to producing bulk and final dosage forms for a variety of vaccine products and is expanding to meet future demands.

The Project team for the Live Virus Vaccine Filling Facility is in search of a dedicated and experienced Senior Operations Specialist to join our team focused on facility management and new vaccine filling & lyophilization operations.

In this role, you will collaborate with various functions to ensure effective facility management, commissioning, qualification, startup, and operational readiness.

This position reports to the Operations Associate Director and necessitates strong leadership and project management capabilities.

Key Responsibilities:


Manage Facility Transition, Operations, and Compliance: Supervise the transition of the facility from commissioning and qualification to operational status, ensuring adherence to safety, environmental practices, cGMPs, and SOPs. Collaborate with cross-functional teams to maintain seamless facility operations and compliance with regulatory standards.

Provide Facility Support:
Serve as the primary contact for facility-related matters and offer assistance to various departments. Identify and resolve facility-related challenges to ensure uninterrupted operations.

Direct the Facility SOP Program:
Develop and execute a comprehensive Standard Operating Procedures (SOP) program for the new manufacturing facility. Ensure all SOPs are current, accurate, and compliant with regulations. Work with subject matter experts to create and review SOPs as necessary.

Manage Change Control:
Oversee change control processes related to facility operations, ensuring proper documentation, evaluation, and implementation of changes. Collaborate with cross-functional teams to assess the impact of changes on facility operations and make necessary adjustments.

Lead Projects in Support of Facility Startup and Improvement: Take charge of projects aimed at enhancing facility operations, efficiency, and productivity.

Coordinate with stakeholders to define project objectives, develop plans, allocate resources, monitor progress, and ensure timely completion.

Ensure Compliance:
Conduct regular audits of facility operations to verify compliance with safety regulations, environmental practices, cGMPs, and SOPs. Identify areas for improvement and implement corrective actions as needed.

Qualifications:
Minimum of 5 years of relevant experience in the pharmaceutical, biotechnology, manufacturing, or related sectors.
Strong understanding of facility design, commissioning and qualification, startup, and operational readiness processes.
Skilled in developing and implementing Standard Operating Procedures (SOPs) for manufacturing environments.
Proven project management expertise, with the ability to lead and prioritize multiple projects concurrently.
Excellent communication and interpersonal skills, with the capacity to collaborate effectively with cross-functional teams.
Detail-oriented with strong analytical and problem-solving skills.
Knowledge of regulatory requirements and compliance standards in the pharmaceutical industry.
Familiarity with cGMPs and FDA regulations.
Bachelor's degree in engineering, life sciences, or a related field, or a High School Degree with relevant work experience.

Preferred Skills/Background:
Experience in facility startup, including equipment and process qualification/validation.
Facility Management experience in a manufacturing/cGMP environment.
Familiarity with Lean Six Sigma or other continuous improvement methodologies.
Knowledge of environmental health and safety practices.
Previous experience in a startup environment or supporting the launch of a new manufacturing facility.
Join our team and contribute to the success of our Drug Product Manufacturing Facility Startup. If you are a collaborative, detail-oriented professional with a passion for facilities management and project execution, we want to hear from you.

  • Rahway, New Jersey, United States MSD Malaysia Full time

    Senior Operations Specialist - Facilities and Project ManagementThe West Point campus is a key manufacturing site for our company, focusing on vaccine production with a workforce exceeding 2000 employees.This facility is dedicated to the production of both bulk and final dosage forms for our vaccine offerings and is expanding to meet future demands.The...


  • Rahway, New Jersey, United States Summit Medical Staffing Nursing Full time

    Job SummarySummit Medical Staffing Nursing is seeking a skilled travel nurse to join their team as an Operating Room Nurse. This is a 13-week contract opportunity that requires a high level of expertise and professionalism.Key ResponsibilitiesProvide exceptional patient care in the Operating Room environmentCollaborate with healthcare teams to ensure...


  • Rahway, New Jersey, United States Springboard Healthcare Full time

    Job DescriptionSpringboard Healthcare is seeking a skilled Diagnostic Imaging Specialist for a travel job in a reputable healthcare facility.Job SummaryWe are looking for a highly motivated and experienced Radiology Technologist to join our team as a Travel Medical Imaging Technologist. As a Diagnostic Imaging Specialist, you will be responsible for...


  • Rahway, New Jersey, United States TotalMed Allied Full time

    Job SummaryTotalMed Allied is seeking a skilled CT Technologist to join our team for a travel assignment in a dynamic healthcare setting.Key ResponsibilitiesOperate CT scanners to produce high-quality diagnostic images for medical professionals.Prepare patients for CT scans, ensuring their safety and comfort throughout the process.Collaborate with...


  • Rahway, New Jersey, United States RNnetwork Full time

    Job SummaryRNnetwork is seeking a skilled travel nurse to join our team in a dynamic day surgery setting.Key ResponsibilitiesProvide high-quality patient care in a fast-paced day surgery environment.Collaborate with the surgical team to ensure a smooth and efficient surgical process.Maintain a sterile environment and adhere to strict infection control...


  • Rahway, New Jersey, United States Tact Staff Full time

    Job SummaryTact Staff is seeking a skilled CT Technologist to join our team as a Travel CT Technologist for a 13-week assignment in a leading healthcare institution.Key ResponsibilitiesPerform high-quality CT scans and diagnostic imaging proceduresOperate and maintain GE CT equipment, including the Optima 660Administer contrast IV injections and ensure...


  • Rahway, New Jersey, United States DPS Group Global Full time

    Position OverviewDPS Group is seeking a highly skilled Senior Process Project Engineer specializing in the biopharmaceutical sector. This role involves overseeing equipment commissioning, calibration tasks, and maintaining documentation within a GMP (Good Manufacturing Practice) environment. The ideal candidate will possess the technical expertise necessary...


  • Rahway, New Jersey, United States Careerbuilder-US Full time

    Job Title: Scientific Project Coordinator Job Location: Rahway, NJ and Upper Gwynedd, PA Job Duration: 12 months+ Pay Range: $55 - $61.87/hr on W2 Shift: Hybrid role - 3 days onsite required each week. Job Overview: We are in search of a proactive and innovative Scientific Project Coordinator who will play a pivotal role in steering our Strategic...


  • Rahway, New Jersey, United States DPS Group Global Full time

    Position OverviewDPS Group is seeking a qualified BioPharma Senior Process Project Engineer to oversee equipment commissioning, calibration activities, and documentation within a GMP environment. The successful candidate will possess the necessary skills and technical expertise to support project timelines, documentation, facilities, and vendor resources,...


  • Rahway, New Jersey, United States DPS Group Global Full time

    Position OverviewDPS Group is seeking a highly skilled BioPharma Senior Process Project Engineer to oversee equipment commissioning, calibration activities, and documentation within a GMP framework. The successful candidate will possess the necessary technical expertise to support project timelines, documentation, facilities, and vendor interactions,...


  • Rahway, New Jersey, United States Asplundh Electrical Testing, LLC Full time

    About the RoleWe are seeking an experienced professional to oversee the installation, testing, and commissioning of instrumentation and control systems in critical facilities construction projects. This role demands a thorough understanding of project requirements, regulatory standards, and advanced control technologies to ensure projects are completed on...


  • Rahway, New Jersey, United States Merck Full time

    Job DescriptionDirector, Strategic Forecasting (Alliances and Pan-Tumor) Our Human Health Digital Data and Analytics (HHDDA) team is innovating how we appreciate our patients and their needs. Working cross functionally we are inventing new ways of engaging, interacting and measuring with our customers and patients leveraging digital, data and analytics.We...


  • Rahway, United States Kelly Services Full time

    The Transportation Planner Specialist will be responsible for supporting and work cross-functionally with Clinical Supply Planning, Master Planning, Clinical Operations, Country Clinical Operations, CMOs/CROs, Logistics, Security, and Trade Compliance.  To support the distribution for Clinical Trial Material utilizing approved transportation networks....

  • SAS programmers

    2 months ago


    Rahway, United States Omni Inclusive Full time

    We are looking for CDISC expert/SME who can handle business queries. The candidate must be very good in SDTM. Looking for 10+ years of clinical SAS programmers having in depth knowledge of CDISC SDTM Gathering data from all available source and using SAS to process it. Creating and writing programs Preparing and presenting operations reports to the mgmt....


  • Rahway, United States Kelly Science, Engineering, Technology & Telecom Full time

    Transportation Specialist IIThe Transportation Planner Specialist will be responsible for supporting and work cross-functionally with Clinical Supply Planning, Master Planning, Clinical Operations, Country Clinical Operations, CMOs/CROs, Logistics, Security, and Trade Compliance. To support the distribution for Clinical Trial Material utilizing approved...


  • Rahway, United States Kelly Science, Engineering, Technology & Telecom Full time

    Transportation Specialist IIThe Transportation Planner Specialist will be responsible for supporting and work cross-functionally with Clinical Supply Planning, Master Planning, Clinical Operations, Country Clinical Operations, CMOs/CROs, Logistics, Security, and Trade Compliance. To support the distribution for Clinical Trial Material utilizing approved...


  • RAHWAY, United States Sodexo Full time

    Unit Description: We are the Communities we serve!This account is part of the SodexoMAGIC portfolio of business.Use your passion for service to create a positive impact and make a difference in the communities we serve! SodexoMAGIC is a joint Sodexo/ Magic Johnson venture and SodexoMAGIC promises to empower the communities we serve by offering best-in-class...


  • Rahway, United States DPS Group Global Full time

    Summary DPS Group has an exciting opportunity for a BioPharma Senior Process Project Engineer responsible for equipment commissioning and calibration activities and documentation in a GMP environment. The ideal candidate will have the skill set and technical competency to support project plans, schedules, documentation, facilities and vendor resources....


  • RAHWAY, United States Sodexo Full time

    Unit Description: We are the Communities we serve! This account is part of the SodexoMAGIC portfolio of business. Use your passion for service to create a positive impact and make a difference in the communities we serve!  SodexoMAGIC is a joint Sodexo/ Magic Johnson venture and SodexoMAGIC promises to empower the communities we serve by offering...


  • RAHWAY, United States Sodexo Full time

    Unit Description: We are the Communities we serve! This account is part of the SodexoMAGIC portfolio of business. Use your passion for service to create a positive impact and make a difference in the communities we serve!  SodexoMAGIC is a joint Sodexo/ Magic Johnson venture and SodexoMAGIC promises to empower the communities we serve by offering...


  • Rahway, United States Atlas Full time

    To enable a squad of IT resources to support SAP Fieldglass system from IT standpoint. The resources should be able to support and have experience on configuring and testing the following two SAP Fieldglass modules: Contingent Labor (Contingent Worker Module). Service Procurement (SOW and SOW Bid): IT Services. Management Advisory Services. Scope of...


  • Rahway, United States Pyramid Consulting, Inc Full time

    Immediate need for a talented Senior Documentation Specialist - III. This is a 15+ months contract opportunity with long-term potential and is located in Rahway, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 24-34389Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to, health...


  • Rahway, United States Pyramid Consulting, Inc Full time

    Immediate need for a talented Senior Documentation Specialist - III. This is a 15+ months contract opportunity with long-term potential and is located in Rahway, NJ(Onsite). Please review the job description below and contact me ASAP if you are interested.Job ID: 24-34389Pay Range: $40 - $45/hour. Employee benefits include, but are not limited to, health...


  • Rahway, United States DPS Group Global Full time

    SummaryDPS Group has an exciting opportunity for a BioPharma Senior Process Project Engineer responsible for equipment commissioning and calibration activities and documentation in a GMP environment. The ideal candidate will have the skill set and technical competency to support project plans, schedules, documentation, facilities and vendor resources....