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Senior Operations Specialist
4 weeks ago
Senior Operations Specialist - Facilities and Project Lead Job Description The West Point, PA campus is our Company’s largest vaccine manufacturing facility with more than 2000 employees. This facility manufactures bulk and/or final dosage forms for all our Company vaccine products and is growing to meet the vaccine demands of the future. The Building 50 Live Virus Vaccine Filling Facility Project team is seeking a highly motivated and experienced Senior Operations Specialist to join our team as a facilities and new vaccine filling & lyophilization facility at the West Point site. As a Senior Operations Specialist, you will be responsible for partnering with multiple functions to execute facility management, commissioning and qualification, startup, and operational readiness activities. This role reports into the Operations Associate Director and requires strong leadership and project management skills. Responsibilities: Manage Facility Transition, Operations, and Compliance: Oversee the transition of the facility from commissioning and qualification to operational status, ensuring compliance with safety, environmental practices, cGMPs, and SOPs. Collaborate with cross-functional teams to ensure seamless facility operations and maintain compliance with regulatory requirements. Provide Facility Support: Act as a point of contact for facility-related issues and provide support to various departments. Identify and address facility-related challenges to ensure smooth operations and minimize disruptions. Direct the facility SOP Program: Develop and implement a comprehensive Standard Operating Procedures (SOP) program for the new manufacturing facility. Ensure all SOPs are up to date, accurate, and compliant with regulations. Collaborate with subject matter experts to author and review SOPs as needed. Manage Change Control: Lead change control activities 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 implement necessary modifications. Lead Projects in Support of Facility Startup and Improvement: Take ownership of projects aimed at improving facility operations, efficiency, and productivity. Coordinate with stakeholders to define project objectives, develop project plans, allocate resources, track progress, and ensure timely completion. Assure Compliance: Regularly audit facility operations to ensure compliance with safety regulations, environmental practices, cGMPs, and SOPs. Identify areas of improvement and implement corrective actions as required. Requirements: At least 5 years of relevant experience in a pharmaceutical, biotechnology, manufacturing or related industry. Strong understanding of facility design, commissioning and qualification, startup, and operational readiness processes. Proficient in developing and implementing Standard Operating Procedures (SOPs) for manufacturing facilities. Proven project management skills, including the ability to lead and prioritize multiple projects simultaneously. Excellent communication and interpersonal skills, with the ability to collaborate effectively with cross-functional teams. Detail-oriented mindset with strong analytical and problem-solving abilities. 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 High School Degree with relevant work history. Preferred Skills/Background: Experience in facility start-up, 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 #J-18808-Ljbffr
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Rahway, United States Merck & Company, Inc. Full timeSenior Specialist, Financial Planning and Analysis. This position operates under the guidance of the Associate Director supporting the Discovery, Preclinical and Translational Medicine (DPTM) organization. The Discovery, Preclinical and Translational Financial Planning, Financial, Specialist, Senior, Planning, Support, Technology
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Lead Operations Specialist
1 week ago
Rahway, New Jersey, United States MSD Malaysia Full timeSenior 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...
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Senior Tax Compliance Specialist
1 week ago
Rahway, New Jersey, United States AA2IT Full timePosition Overview:As a Senior Tax Compliance Specialist at AA2IT, you will play a crucial role in ensuring the accuracy and timeliness of tax-related processes within our organization. This part-time position requires you to be on-site a few times a week, allowing for collaborative efforts with our team.Qualifications:Education: Bachelor’s degree...
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Senior Documentation Specialist
2 months ago
Rahway, United States Pyramid Consulting, Inc Full timeImmediate 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...
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Senior Documentation Specialist
4 weeks ago
Rahway, United States Pyramid Consulting, Inc Full timeImmediate 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...
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Rahway, New Jersey, United States HCLTech Full timeHCLTech is seeking a highly skilled and self-driven Senior Appian Business Process Management Specialist to contribute to our mission of advancing the technological landscape through innovation and creativity.Position Type: Full-timeLocation: OnsiteKey Responsibilities:The ideal candidate will possess advanced proficiency in Appian BPM, demonstrating...
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Senior Project Engineer
3 days ago
Rahway, United States Merck & Company, Inc. Full timeThis Engineer Senior Specialist (P 3) position will provide compliance project engineering leadership for the Rahway, NJ FL - Ex (Formulation, Laboratory & Experimentation) center, including the RY 119 Development center and the WP Sterile Liquids pi Project Engineer, Engineer, Project Management, Senior, Project, Support, Business Services
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SBA Loan Operations Specialist
1 week ago
Rahway, New Jersey, United States Northfield Bank Full timeJob OverviewNorthfield Bank, a comprehensive financial institution with numerous branches, is dedicated to fostering growth and providing exceptional service to our clients. Our team, comprised of over 300 diverse professionals, is committed to creating a supportive environment that encourages career advancement and personal development.Position: SBA Loan...
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Operations Expert
1 week ago
Rahway, New Jersey, United States MSD Malaysia Full timeSenior Operations Specialist - Facilities and Project Lead Job DescriptionThe 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...
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Senior Specialist, Audit
3 months ago
Rahway, United States Merk Full timeJob Requirements This posting has been created to pipeline talent for prospective roles that we anticipate will be needed in the future for our organization. By applying to this Pipeline Advertisement you will be submitting your interest to be contacted for roles similar to what is described in the Pipeline Advertisement.Expand your skills and experience in...
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Marketing Specialist
2 weeks ago
Rahway, United States MSD Malaysia Full timeMARKETING SPECIALIST OVERALL OBJECTIVE Responsible for planning, development and implementation of marketing strategies to generate higher levels of company business. SALES ATTAINMENT/SALES GROWTH Develops marketing plans in order to achieve agreed sales and area development targets and ensures their implementation among all concerned. Monitors sales...
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Personal Support Specialist
1 week ago
Rahway, New Jersey, United States Home Helpers of East Peoria Full timeJob OverviewAt Home Helpers of East Peoria, we take pride in our reputation for employee satisfaction and our unwavering commitment to the families we serve. Our dedicated team plays a vital role in providing care to individuals in their homes, and we are continuously seeking compassionate and skilled individuals to join us.We are expanding our workforce and...
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Rahway, United States MSD Malaysia Full timeSenior Principal Scientist/Senior Director, Precision Bioinformatics Job DescriptionThe Precision Genetics group within the Data and Genome Sciences Department is recruiting a Sr. Principal Scientist, Precision Bioinformatics site lead for our San Diego based Companion Diagnostics (CDx) efforts. We are seeking an experienced computational biologist with a...
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Rahway, New Jersey, United States DPS Group Global Full timePosition 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,...
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Laboratory Computing Specialist
7 days ago
Rahway, New Jersey, United States firstPRO, Inc Full timeCompany Overview:firstPRO, Inc. is seeking a skilled professional for the role of Laboratory Computing Specialist. This position is essential in providing technical support within a pharmaceutical laboratory environment.Role Overview:The Laboratory Computing Specialist will collaborate with the lab computing team and clients to address and resolve technical...
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Rahway, New Jersey, United States MSD Malaysia Full timeSenior Principal Scientist/Senior Director, Precision BioinformaticsMSD Malaysia is seeking a highly experienced computational biologist to lead our Companion Diagnostics (CDx) efforts in San Diego.Job Summary:We are looking for a senior leader to oversee the development of a flexible AI/ML engine for precision bioinformatics, leveraging human data to...
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Transportation Planner Specialist II
2 weeks ago
Rahway, United States Kelly Science, Engineering, Technology & Telecom Full timeTransportation 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...
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Transportation Planner Specialist II
3 weeks ago
Rahway, United States Kelly Science, Engineering, Technology & Telecom Full timeTransportation 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...
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Medical Sales Specialist
1 week ago
Rahway, New Jersey, United States MSD Malaysia Full timeMedical Sales Specialist - WestOur Sales division is dedicated to supporting healthcare professionals by delivering clinical insights about our offerings, educational resources, and training programs. We collaborate with healthcare providers and systems to help achieve the health objectives of patients in their communities.We are in search of exceptional...
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Vice President of Administrative Operations
1 week ago
Rahway, New Jersey, United States RWJBarnabas Health Full timeChief Administrative Officer - RWJBarnabas HealthOverview:The Chief Administrative Officer (CAO) at RWJBarnabas Health will be responsible for formulating, implementing, and steering the strategic and operational framework of the organization, ensuring alignment with overarching goals while addressing the needs of the community and patient population.The CAO...