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8.0 - 13.0 years
8 - 13 Lacs
Bengaluru / Bangalore, Karnataka, India
On-site
Position Responsibilities: As a Lead Systems Engineer, your primary responsibilities will include: Certification Documentation: Authoring and updating certification process documents, templates for system certification plans, and other associated certification documents. Resource Development: Developing and compiling internal and external resources to support system certification activities, including project-specific certification plans and System Safety Assessments, as needed per SAE ARP 4754/4761. Regulatory Compliance: Ensuring compliance with SAE ARP 4754/4761 and all applicable FAA regulations (FARs) within process documents. Compliance Demonstration: Writing accomplishment summaries and certification summaries to demonstrate compliance with applicable regulations. Systems Lifecycle Oversight: Providing oversight of System Lifecycle Development, including Requirement Engineering, Configuration Management, and Verification & Validation (V&V). Review and Participation: Participating in reviews of test plans, procedures, and supplier documentation to ensure compliance with certification regulations and processes. Participating in test witnessing and conformity reviews. Coordination: Coordinating with subcomponent teams and suppliers to ensure compatibility of system certification processes. Presentations: Preparing and presenting technical presentations, decision points, and process changes to formal change boards and technical councils. Process Adherence: Working with cross-functional teams to foster process adherence, compliance, and a strong safety mindset. Documentation Contribution: Contributing to writing system engineering and development plans, system certification documents, process documents, and work instructions. Feedback Integration: Working with Compliance Finders/Engineering Unit Members (E-UM) to incorporate feedback on system process documents. Audits & Reviews: Coordinating and participating in Development Assurance Reviews (DARs) and Process Assurance Reviews (PARs), and being an integral part of the project team to demonstrate compliance. Risk Management: Managing certification risks for products and projects, and performing Requirements Management in DOORS. Process Development: Developing the planning, organization, implementation, and monitoring of tools, risk, issues, and opportunity management processes. Team Leadership: Leading a local team of Process Assurance Engineers, providing daily direction for tasks and assignments. Reporting: Providing team activity reports to the Engineering Manager. Basic Qualifications (Required Skills/Experience): Education: Bachelor's degree or higher is required. Experience:8+ years of demonstrated experience in process and certification methodologies. 12 to 14 years of Systems Engineering experience with exposure to system certification processes and activities. Standards & Regulations: Experience with SAE ARP 4754 Systems Development Process and ARP 4761 Safety Assessment. Knowledge of FAA ACs, ADs, and CFRs PART 21, 23, 25, 27, 29. Understanding of DO-178C, DO-254, DO-160. Systems Expertise: Extensive experience with systems engineering and system development processes. Working experience with Level A System/Equipment/AEH. Demonstrated strict adherence to processes and compliance requirements. Experience and understanding of configuration status accounting processes. Audits & Guidance: Experience with Development Assurance Reviews (DARs) and Process Assurance Reviews (PARs)/Compliance Finding Audits. Experience guiding and mentoring teams on compliance topics. Ability to guide leadership on handling certification topics. Problem Solving & Management: Strong problem resolution skills, process management skills, and stakeholder management abilities. Teamwork & Initiative: Ability to work in a virtual team environment. Takes part in organizational initiatives and demonstrates ownership of the statement of work in review meetings. Communication: Strong written and verbal communication skills for interaction with engineers, management, and non-engineering support staff. Preferred Qualifications (Desired Skills/Experience): Safety Assessment: Exposure to SAE ARP 4761 for Safety Assessment. System Architecture: Exposure to Systems architecture, design of Avionics LRU components. IMA Architecture: Basic understanding of Integrated Modular Avionics (IMA) architecture. INCOSE Certification: INCOSE certification on Systems Engineering is an added advantage. Agile Awareness: Awareness of Agile framework. Typical Education & Experience: An Engineering degree and typically 13+ years related work experience, or a Master's degree and 12+ years related work experience, or an equivalent combination of education and experience. Relocation: This position does offer relocation based on candidate eligibility within INDIA. Education: Bachelor's Degree or Equivalent Required.
Posted 1 month ago
9 - 12 years
20 - 27 Lacs
Hyderabad
Work from Office
Job Description The Manager, CSAR - Electronic Data Interchange and Acquisition will report to the Sr. Manager, Clinical System and Analytical reporting and will be focused on supporting Electronic Data Interchange/Acquisition programming activities. The Manager, CSAR - Electronic Data Interchange and Acquisition will develop the Data Acquisition Requirements Specification (DARS) document to outline metadata transfer requirements, establish and validate vendor integration criteria, and manage the processing of electronic data from vendors. The position is expected to partner effectively with other CSAR Operations and cross functional staff to seamlessly ensure high quality deliverables, internal and external clinical systems, and other CSAR activities related to the use electronic data capture technology. The position will be responsible for quality and deliverables at the study and portfolio level. Manager, CSAR - Electronic Data Interchange and Acquisition will also be expected to help deliver large system transformation projects, with a focus on project management, contribution of subject matter expertise, partner engagement, and change management. The successful candidate will be a strong leader with demonstrated ability to influence partners, while also acting as an individual contributor on study specific and general CSAR/Global Development Operations projects or operational work. Proven capability of providing support for study deliverables. Has operational experience with clinical database management systems and allied technologies (e.g., Rave EDC, Veeva EDC). Responsibilities include, but are not limited to, the following: Support of clinical trial platform technologies Support decision-making by acting as a data scientist bringing awareness to patterns and analytical insight. Coordinating and providing programming support to Clinical Study Teams Works collaboratively with Clinical Data Management to meet study deliverables and timelines Acting as a technical point of contact for systems deliverables on defined programs Experience in writing the Data Acquisition Requirements Specification (DARS) document to specify metadata transfer requirements, setting up and testing RWS integration requirements supporting study closure with final data loads and transfer discontinuation, configuring data upload gateways between external vendors and Amgen. Providing technical and business process input / expertise on new and emerging technologies Develop, review and implement policies, SOPs and associated documents Assist in preparing for and responding to audit findings (internal or external). What we expect of you Good Clinical Practice Strong understanding and experience in the use of performance management techniques, measures, problem-solving and analytical thinking. Drug development and clinical trials processes Data management processes Programming of clinical trial databases and applications Experienced in collecting, maintaining, aggregating, and supporting data cleaning controls for external (non-EDC) data, importing clinical study data from various sources including central labs and imaging vendors. Systems development lifecycle Programming Languages Project planning and management Collaborating with global cross-functional teams (team/matrix environment) Quality management and Risk Analysis Regulatory filings and inspections Process improvement methodologies Preferred Qualifications Advanced degree or equivalent in life science, computer science, math, statistics, business administration or related field with 9-13 years of experience Broad knowledge / work experience in data management / programming in the Pharmaceutical or Biotech arena Proven experience in managing teams General project management and planning experience Experience in oversight of outside vendors (CRO's, central labs, imaging vendors, IRT vendors, etc.) Basic Qualifications Bachelors degree or equivalent in life science, computer science, business administration or related field with 9-13 years of experience. Proven experience in managing teams Specialist knowledge / experience in life sciences or a medically related field General biopharmaceutical clinical research experience (clinical research experience obtained working on clinical trials at a biotech, pharmaceutical or CRO company)
Posted 2 months ago
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