10 engineering specialist jobs found

CSL The Lead, Global Regulatory Affairs Device is responsible for: Developing, coordinating and implementing global Software as a Medical Device regulatory strategies for new combination and standalone medical devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with regulatory agencies. This role promotes strong cross-functional collaboration and effective communication across Global Operations, Plasma Operations, R&D, Global Regulatory Affairs, and other relevant CSL business functions to...

CSL The Lead, Global Regulatory Affairs Device is responsible for: Partnering closely with R&D, Manufacturing, Operations, Quality, and Regulatory Affairs stakeholders to address regulatory strategy challenges and deliver innovative, timely regulatory solutions that meet evolving device regulatory and compliance requirements for plasmapheresis devices, drug device combination products, standalone drug delivery devices, and ancillary devices. Ensure worldwide regulatory device compliance and successful market access across all regions. Closely collaborate with internal stakeholders on regulatory strategy issues, develop approaches to address regulatory and compliance matters, serve as primary liaison to the US FDA for device matters, and closely work regional regulatory staff to engage with international health authorities. Represening CSL in official device regulatory capacities and acting as an authorized official or responsible person in interactions with...

Merck Job Description Position Overview The Senior Specialist, Data & Analytics plays a critical role in advancing data-driven decision-making across Animal Health Global Supply Chain Management (AH GSCM). This position sits at the intersection of analytics, digital supply chain systems, and operational execution-transforming complex, multi-system data into scalable insights that improve service, inventory performance, manufacturing reliability, and risk mitigation in a regulated manufacturing environment. In this role, you will move beyond reporting to architect analytical solutions that directly influence planning parameters, supply network decisions, performance management, and continuous improvement initiatives. You will work cross-functionally with Supply Chain, Manufacturing Operations, IT, Finance, and Quality stakeholders to translate business challenges into structured data models, automated dashboards and system-integrated analytical tools that drive...

Merck Job Description This position reports to the Associate Director, Global Clinical Supplies Quality, and is critical in maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug Applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc. Primary duties may include but are not limited to the...

Merck Job Description Position Overview The Senior Specialist, Data & Analytics plays a critical role in advancing data-driven decision-making across Animal Health Global Supply Chain Management (AH GSCM). This position sits at the intersection of analytics, digital supply chain systems, and operational execution-transforming complex, multi-system data into scalable insights that improve service, inventory performance, manufacturing reliability, and risk mitigation in a regulated manufacturing environment. In this role, you will move beyond reporting to architect analytical solutions that directly influence planning parameters, supply network decisions, performance management, and continuous improvement initiatives. You will work cross-functionally with Supply Chain, Manufacturing Operations, IT, Finance, and Quality stakeholders to translate business challenges into structured data models, automated dashboards and system-integrated analytical tools that drive...

Merck Job Description This position reports to the Associate Director, Global Clinical Supplies Quality, and is critical in maintaining the global clinical supply chain via disposition activities for clinical finished goods provided by our Company for worldwide clinical trials. Specifically, this includes batch documentation review ensuring our clinical supplies are in compliance with current Good Manufacturing Practices (cGMPs) regulations and relevant regulatory filing submissions. Areas of focus of this position revolve around the detailed workings of clinical packaging, labeling and distribution activities and associated regulatory submissions for Investigational New Drug Applications and Clinical Trial Applications in relation to complex/niche supply chains and supply types for clinical protocols as well as Managed Access Programs, Joint Ventures/Collaborations, Independent Investigator-Initiated Studies, etc. Primary duties may include but are not limited to the...

Land O'Lakes Night Shift Operations Specialist The Operations Specialist is an integral part of the Technical Services Department, serving as an on-the-shop-floor leader during the night shift. This role is primarily focused on supporting manufacturing operations and ensuring smooth facility performance. The Operations Specialist provides backup supervision, prepares the floor for corporate R&D research projects, and actively participates in the execution of ongoing capital improvements. The majority of work hours will be spent directly on the manufacturing floor, supporting production teams and operational excellence. Schedule: Nightshift is 6PM-6AM; 2-2-3 Rotating-Shift Schedule Salary Range: $79,000-$100,000 Annual Key Responsibilities Lead shop floor teams to improve plant performance and efficiency, fostering informed decision-making and enhancing employee satisfaction and relations. Serve as a backup production supervisor for all shifts, providing...

Wabtec Job Description Role Summary/Purpose The Lead Production Quality Specialist for the Building 18-1 Compartment team will develop and maintain systems, rules, and processes to ensure customer satisfaction and fulfillment of internal and external requirements. In this role, you will be responsible for managing day-to-day quality functions and resolving issues highlighted during inspections. Ensures that processes and products are capable and will meet specified standards. Requires developed and strong foundation of function skills and knowledge of relevant technologies, products, and processes. Candidate will be responsible for failure investigation and customer reviews/interface. Communication with cross functional team to drive quality initiatives.   Essential responsibilities: *  Develop Quality Culture improvements in coordination with the Plant Quality Leader *  Ensure that the Manufacturing Quality Management System complies with all Wabtec and customer...

Wabtec Job Description Locations: Hybrid  Pittsburgh, PA; Atlanta, GA; Fort Worth, TX;  Remote  California and the UK.  How will you make a difference? The Data Privacy Specialist supports enterprise-wide privacy compliance by partnering with cross-functional teams to embed data protection requirements into products, processes, and contracts. You will manage key privacy operations-including data mapping, Data Protection Impact Assessments, system maintenance, and data subject requests-while driving process improvements, training initiatives, and alignment with evolving global privacy laws. This role plays a critical part in strengthening the company's privacy posture and maintaining customer trust. Preferred locations: United Kingdom / Atlanta, GA / Dallas-Fort Worth, TX, Pittsburgh, PA, California.  If you are located near a Wabtec hub, you must be available to work the onsite-hybrid schedule.  Alternative remote locations may also be considered.  What do we want...

Doyon Management Services Overview: Doyon Management Services, LLC (DMS) provides Design-Build and General Construction Services on demolition, new construction, renovations, repairs, and civil projects at government-owned facilities and military installations. We work with government clients to meet agency goals and deliver high quality construction projects in the safest manner possible. The construction Quality Control Manager (QCM) holds the primary responsibility of directly reporting to the Project Manager and Corporate Management regarding the verification of adherence to all quality standards across our projects. Operating at the project level, the Quality Control Manager plans, coordinates, and supervises the implementation of construction quality control and quality assurance programs. Additionally, this position is tasked with creating, reviewing, and amending Project Quality Plans to keep current and ensure compliance with the contract, established...