Cell Therapy Manufacturing Specialist - Night Shift

We are seeking a skilled SAP Infrastructure Specialist to join our team in Bridgewater, NJ. In this full-time permanent role, you will be responsible for designing and reviewing architecture solutions tailored to meet the infrastructure demands of SAP Business Suite on HANA and S/4. Your expertise will be vital in testing newly implemented systems and featur…

As a SAP Solutions Architect at AYR Global IT Solutions, you will play a pivotal role in shaping and executing strategic initiatives for our SAP platform. Leveraging your expertise, you will develop innovative SAP solutions that enhance operational efficiency and exceed the expectations of our business partners. You will stay abreast of industry trends and best practices, ensuring our solutions are not only effective but also forward-thinking.Your responsibilities will include fostering a culture of innovation within a dynamic environment, characterized by adaptability, scalability, reliability, and security. You will build strong relationships with solution architects across various technology organizations, collaborating to establish and promote best practices in architectural design and integration.In this role, you will work cross-functionally with key stakeholders in all Client IT groups, aligning technology standards with the strategic growth goals of the organization. Your ability to take ownership of complex problems and drive them to resolution will be crucial in influencing the future IT landscape.

As a SAP Solutions Architect, you will play a crucial role in developing and implementing strategic plans that enhance our SAP platform. Your expertise in SAP systems will be invaluable as you collaborate with various business partners to create innovative solutions that exceed expectations. You will stay abreast of industry trends and best practices, promoting a culture of innovation within our dynamic environment, which emphasizes adaptability, scalability, reliability, and security. Your ability to build strong relationships with solution architects across our technology organization will facilitate the development and promotion of architectural and integration best practices. Additionally, you will partner with key stakeholders across all PVH IT groups, ensuring alignment and collaboration in the development of technology standards focused on selected SAP applications that support our organizational growth and shape the future of our IT landscape. Your ownership of open-ended challenges will drive these initiatives to successful completion.

Join our dynamic team at eproinc as a SAP Solution Architect in our Center of Excellence (CoE) Delivery. This is an exciting opportunity for a seasoned professional looking to leverage their skills in a collaborative environment. As an SAP Solution Architect, you will play a crucial role in delivering innovative solutions that drive business success.

We are seeking a talented and dynamic Communication Specialist to join our team at Integrated Resources, Inc. In this role, you will be responsible for developing and implementing effective communication strategies that engage our stakeholders and enhance our brand image. Your exceptional writing and interpersonal skills will be crucial in crafting messages that resonate with our audience.

We are seeking a dedicated and experienced Regulatory Affairs Specialist III to join our team in Bridgewater, NJ. In this pivotal role, you will be responsible for ensuring compliance with regulatory requirements and managing submissions to various health authorities.Your expertise will play a vital role in supporting the development and marketing of pharmaceutical products. You will collaborate with cross-functional teams to prepare and submit regulatory documents, analyze regulatory changes, and ensure adherence to industry standards.

Join our dynamic Operations team as a Manufacturing Support Services Specialist at Cellares in Bridgewater, NJ. In this vital role, you will play a key part in the advancement of our cutting-edge cell therapy manufacturing platform. Your primary responsibilities will involve supporting both manufacturing and daily warehouse operations, ensuring smooth and efficient processes. This is a hands-on position that will provide you with in-depth training alongside our Manufacturing and Warehouse Team.We are looking for candidates who thrive in a fast-paced, mission-driven environment and are eager to embrace a variety of challenges as our company continues to grow.

Join our dynamic team as a Regulatory Affairs Specialist-V and play a pivotal role in ensuring compliance with regulatory standards in the pharmaceutical industry. You will be responsible for managing regulatory submissions, liaising with regulatory agencies, and ensuring that our products meet all necessary guidelines.

Join our dynamic team at Integrated Resources, Inc. as a Virtualization and Server Administration Specialist. In this role, you will be responsible for managing and optimizing our virtualization infrastructure, ensuring high availability and performance of our server systems. You will work closely with cross-functional teams to implement best practices and enhance our server management processes. This is an excellent opportunity for individuals passionate about technology and eager to make a significant impact in a collaborative environment.

About Spectrum VascularSpectrum Vascular is a pioneering medical device firm dedicated to enhancing vascular access and medication management. Our mission is to improve patient outcomes globally by equipping caregivers with high-quality, innovative products and exceptional customer service. Formed through the integration of a trusted portfolio of widely used products, innovation remains a strategic pillar of our journey. Our designs focus on delivering antimicrobial and antithrombogenic protection, catering to critical care and pediatric patient needs. This role offers a unique chance to join a dynamic team with established products and an entrepreneurial spirit.Role Overview:The Regulatory Affairs Specialist plays a crucial role in supporting global regulatory submissions and ensuring compliance for medical device products throughout their lifecycle. This position requires collaboration with Quality, Engineering, Clinical, and Manufacturing teams to effectively prepare, submit, and maintain regulatory filings with agencies such as the U.S. FDA, European Notified Bodies, and other international authorities.Assist in the preparation, formatting, and compilation of regulatory submissions (e.g., FDA 510(k), EU MDR Technical Documentation, Health Canada, and other global filings).Maintain regulatory files, declarations of conformity, and device registrations.Respond to regulatory agency requests for additional information (AIs, deficiency letters, technical queries).Support U.S. and EU market approval processes, ensuring adherence to regulatory standards.Assist with post-market submissions (progress reports, annual reports, etc.).Provide regulatory assessments for marketing, R&D, and manufacturing changes or product transfers.Communicate with distributors concerning information requests, regulatory inquiries, and support for regulatory filings.Compliance & Quality System SupportCollaborate with Quality Assurance to maintain compliance with relevant regulatory standards, including FDA 21 CFR 820, ISO 13485, and EU MDR 2017/745.Participate in internal audits, management reviews, and preparations for external audits as necessary.