Solution Architecture & Design

• Design Reporting and Analytics Solutions: Architect scalable and high-performance BI solutions leveraging SAP BW on HANA, SAP HANA, SAP Analytics Cloud (SAC), and SAP BusinessObjects (BO).
• Integrate SAP Data with BI Tools: Ensure smooth integration of SAP systems (e.g., SAP S/4HANA, SAP BW) with SAC, BO, and other third-party reporting tools.
• Define Data Models: Design logical and physical data models for BW/4HANA, ensuring optimal data flow, storage, and performance for reporting.
• Define ETL Processes: Develop and optimize Extract, Transform, Load (ETL) processes for data migration and reporting, including data extraction from various sources and transformation rules.
• Establish Architecture Standards: Define and document architecture standards, guidelines, and best practices for SAP BW HANA, SAC, BO, and ABAP reporting.
Implementation & Configuration • Configure SAP BW on HANA: Oversee the configuration of SAP BW on HANA, including data modelling, creating InfoObjects, InfoProviders, transformations, and data sources.
• Develop ABAP Code for Custom Logic: Write and optimize ABAP programs, function modules, and reports to handle complex data extraction, transformation, and custom reporting requirements.
• SAC Integration & Setup: Implement and configure SAP Analytics Cloud (SAC) to visualize BW data, integrate SAC with SAP BW/4HANA for real-time reporting.
• BO Reports and Dashboards: Develop and configure reports, dashboards, and web intelligence documents in SAP BusinessObjects (BO) based on the data model in SAP BW/4HANA.
• Data Federation & Virtualization: Implement virtual data models (VDM) and use SAP HANA Smart Data Access (SDA) for federated data access across different sources.
Performance Optimization & Troubleshooting • Optimize Query Performance: Monitor and optimize the performance of BW/4HANA queries, HANA views, and SAC reports, ensuring fast data retrieval and responsiveness.
• Troubleshoot Issues: Identify and resolve technical issues related to data extraction, reporting, or integration within the BW/4HANA, SAC, or BO environments.
• Data Governance & Quality: Implement strategies for data quality management, ensuring data consistency and compliance with governance policies.
Reporting & Analytics Delivery • Report Development in SAC and BO: Work with business teams to gather reporting requirements, design, and implement interactive dashboards and reports in SAC and BO.
• Data Visualization: Apply best practices for data visualization to ensure users can easily interpret the data and make data-driven decisions.
• Custom Analytics Solutions: Develop custom analytics solutions using ABAP and HANA for specific business needs or complex calculations that cannot be handled by standard reports.
Collaboration with Stakeholders • Liaise with Business Users: Collaborate with business analysts, stakeholders, and end users to understand reporting needs, translate business requirements into technical specifications, and ensure alignment between the technical solution and business objectives.
• Lead Cross-Functional Teams: Lead and mentor a team of SAP BW developers, ABAP developers, and BI consultants in implementing and delivering reporting solutions.
• User Training & Support: Provide training sessions and documentation for business users to maximize the adoption and efficiency of reporting tools like SAC and BO.
Project Management & Documentation • Project Planning & Management: Participate in project planning, estimating efforts, and managing timelines for the design and delivery of SAP BW/4HANA, SAC, and BO reporting solutions.
• Documentation: Ensure comprehensive technical documentation is prepared and maintained for all custom developments, configurations, and architectural designs.
System Maintenance & Upgrades • System Upgrades: Plan and execute system upgrades for SAP BW/4HANA, HANA databases, and reporting tools, ensuring minimal downtime and a smooth transition.
• Patch Management: Ensure the application of patches and updates to SAP BW/4HANA, SAC, BO, and underlying systems, maintaining the system's security, stability, and performance.
• Backup & Recovery: Implement backup and disaster recovery strategies to ensure the protection of critical business intelligence data.
Security & Compliance • Role-Based Access Control (RBAC): Implement role-based access control in BW/4HANA, SAC, and BO to ensure that users have the right level of access based on their roles.
• Data Privacy Compliance: Ensure that reporting systems comply with legal requirements and corporate policies regarding data privacy and protection (e.g., GDPR).
Innovation & Continuous Improvement • Stay Up-to-Date with SAP Technologies: Keep abreast of the latest developments in SAP HANA, BW/4HANA, SAC, and BO technologies and evaluate new features for possible implementation.
• Propose Improvements: Regularly propose new solutions, tools, or processes that could improve the overall performance and capability of reporting systems.

Qualifications

• Bachelor's Degree is required in Computer Science or Computer Engineering or Electronics Engineering or Computer Information systems

Location : Eatontown, NJ

Job description

• Establish and maintain a master validation program, including site and individual products and process master validations
• Create/Review/Support validation protocols and reports to support process and reliability improvements.
• Support complaint handling program, including complaint analysis, investigation, and follow-up.
• Lead and/or support reliability and process improvement projects from a qualityperspective .
• Establish and maintain process controls/SPC for specific production processes.
• Support corrective and preventive action (CAPA) program.
• Review and modify product designs and process documentation for qualitycharacteristics,
• including manufacturability, serviceability, testability, reliability, and conformance to product and qualitysystem requirements.
• Demonstrate product compliance for sterilization, biocompatibility, package integrity, shelf life, reliability, and electrical safety.
• Review and provide feedback of protocols and reports, test vendor qualification, and testing management.
• Assist with the development and maintenance of product risk management files
• Recommend requirements for first article inspection, incoming and in-process inspections, and lot release testing, including sampling strategy and test methods.
• Participate in failure investigations to analyze internal system or process failures and to implement corrective and preventive action
• Participate in component and service new supplier evaluation. Works with suppliers to ensure appropriate qualitycontrols are implemented
• Audit Design History Files and works with cross-functional team to resolve documentation issues Identify and implement good qualityengineering practices, including statistical methods and root cause analysis tools
• Participate in supplier material-related processes which include coordination of MRB activities to ensure the timely assessment of potential non-conforming products
• Support continuous product and process improvement through detailed failure analysis for non-conformances, and investigate, develop, and implement effective and compliant solutions for product or process corrections, retrospective and remediation action plans, and for corrective and preventive actions
• Demonstrate the ability to implement ISO 14971, including risk evaluation techniques

Qualifications

• Bachelor's degree preferably in an engineering or scientific discipline from a four-year college or university
• 5+ years related experience and/or training; or equivalent combination of education and experience
• Medical Device or Class II device experience preferred, will consider experience from other regulated industries such as pharmaceutical, military or nuclear
• A working knowledge of the FDA QualitySystem Regulation, ISO 13485, ISO 14971,
• ISO10993, ISO 11135, and the EU Medical Device Directive is a plus
• Familiarity with test methods and standards for the design, verification, and validation of medical device products are required
• Experience with PPAP, PMEA

Location : Irvine, CA(Onsite)

Job description

• GMP (Good Manufacturing Practices) & ISO (International Organization for Standardization) 9000 and regulatory affairs.
• Strong creative, analytical and problem-solving skills.
• Proficient at interpreting data and putting that data into a report.
• Proficient at statistical analysis
• Experience in EU MDR or other regulatory related projects
• Verification and Validation
• CAD Support (Preferred Auto CAD and Solidworks)
• Experience in creating PFMEAs & Writing reports
• Process experience, ability to observe and understand manufacturing processes
• Excellent Interpersonal / communication skills, Organizational / planning and Project management skills preferred
• Personal computer skills, Windows: word processing, presentation, e-mail, web browsers & spreadsheet software
• Ability to work efficiently, meet timelines, and communicate status (generate trackers, send emails, etc.)

Systems Engineer is needed to perform the following duties:

• Writing efficient, testable code using best software development practices.
• Working with cross-functional teams.
• Designing and developing user-friendly websites.
• Creation of site layout/user interface from provided design concepts by using HTML/CSS, Bootstrap, jQuery, JavaScript, Angular.
• Maintaining websites: Updating websites to meet new design trends or security standards
• Testing web applications: Checking websites regularly to catch errors early.
• Troubleshooting: Identifying, categorizing, and articulating problems that occur in applications.
• Designing websites: Designing websites based on general best practices and guidelines from clients.
• Understanding client needs: Translating client requirements into application features Maintaining technical documentation
Bachelor's Degree is required in Computer Science or Computer Engineering or Information Systems or Information Technology.

Location : New Brunswick, NJ

Job description

• Working as part of a team dealing with global market registrations and providing regulatory compliance/Affairs guidance, and support to all External Manufacturing groups.
• Coordination of EXM quality dossier (Module 2 and 3) review process for Pharmaceutical and Biologics products at all nodes of the supply chain for new product introductions, and post approval variations including but not limited to new manufacturing facilities and process changes.
• Point of Contact for requests to source and provide relevant regulatory documentation (e.g. SOPs, Technical Reports, CoA’s, Analytical raw data) to support regulatory requests for post approval variations, renewals, and annual reports
• Support product release by managing appropriate systems to ensure product market compliance to enableseamless release of finished products to the market.
• Review of local and global change controls, deviations, CAPA’s, technology transfer plans, and regulatory submission plans.
• Maintains strong communication and working relationships with all departments, contract manufacturing organizations, and global personnel such as CMC.
• Participating in other QA supporting activities as required (e.g. internal audits, site regulatory inspections, APQR’s,quality risk management)

Qualifications, Knowledge and Skills Required:

• The successful candidate will have a minimum of 3 years Quality/Compliance/Technical experience in a biopharmaceutical Affairs role
• Regulatory experience and familiarity with regulatory dossier sections (Module 2 and 3) would be advantageous
• Bachelor's Degree in a related field
The candidate should be able to demonstrate:
• Ability to work independently and within team matrix environments.
• Ability to manage teams associated with individual aspects of responsibilities, direct people management and project management aspects.
• Thorough knowledge of worldwide regulatory Good Manufacturing Practices (GMP) requirements and a working knowledge of Food and Drug Administration (FDA) & European Union (EU) GMP requirements.
• In depth knowledge of Quality Management Systems with an emphasis on change control principles and the applicability of restriction/regulatory holds in the release process for changes that require health authority approval.
• Ability to assess the right balance between the business implications, technical considerations and quality decisions
• Excellent organizational and administration skills are required in addition to strong interpersonal skills.
• The successful candidate must be able to prioritize, organize and manage multiple tasks to tight deadlines.

Location : Norwood, MA

Duration : 3-4 Months contract

Interview : telephonic and webex

Job description

Our client is looking to bring on an Equipment Validation Engineer. This work will be 100% on-site in MA. The client is moving equipment in from another facility and needs to have all the equipment requalified and revalidated. This Consultant will be supporting the move of equipment and IQ/OQ/PQ. There will be protocol writing, protocol reporting, and protocol execution. They need to be well versed in IQ, OQ, and PQ. Need to be able to create protocols and executing through to reporting. Medical Device experience is a must on this one. Catheter experience would be a plus.

Most Important Skills :

Equipment Validation, Equipment Qualification, Protocol Creation, IQ, OQ, PQ, Medical Device

Location : Pleasanton,CA 94588

Duration : 6 Month

Job description

• Creo or solid works
• Masters with a couple of years of experience  
• Any industry experience will work And mechanical experience 
• Not required regulated industry experience (any experience will work 3 d plastic experience is preferred   
• looking for more skills compared to more experience  
• Modification in the plastic part  
• Product line
• Cad skills 
• Mechanical engineer
• R&D engineer will also work  
• mechanical engineering experience  
• Any experience will work  
• Designing in the cad 
• Looking for a local candidate is preferred (but fine with non-local candidates if no problem in onboarding) 
• Testing design and helping in the design  
• Plastic experience is really important  
• Plastic Design 

Description Details:

• The Contractor Engineer Combination Products works with technical supervision on project teams in support of medical devices.
• Activities include contributing to product design documentation and conducting laboratory studies of product performance in support of product development, manufacturing transfers and investigations and product enhancements. Products are intended for electromechanical devices with integrated software.
• Work is conducted in compliance with device design controls (FDA 21CFR820.30 and/or ISO 13485) as applicable.
• Special interest in candidates with mechanical design and drawing proficiency and execution and validation with emphasis on mechanical seal design.

Primary Function / Primary Goals / Objectives:

• Generate CAD data models and drawings.
• Participate/lead prototype build of new designs.
• Conduct independent laboratory work and data analysis
• Place data in proper scientific context by consulting and citing relevant literature
• Understand and adhere to corporate standards regarding code of conduct, safety, medical device design controls and GxP compliance.

Level of Expertise:

• Able to work in a regulated environment
• Familiar with lab environment and safety practices.
• Applies basic computer skills in support of data analysis
• Proficient in mechanical design using Ceo or Solidworks and generating specification documents and drawings
• Applies technical writing skills to produce technical reports and documents

Level of Leadership Activities:

• Works under direction of senior staff
• Summarizes and presents results of projects to project teams

Level of Interpersonal Skill:

• Works in team environment
• Collaborates with others on design and data analysis
• Able to present work to small groups

Intake Notes
Are you open to look at candidates willing to relocate ?N/A

Years of experience/education and/or certifications required : Bachelors Degree or equivalent education in Mechanical or related field with 5+ years of experience (starting point)

What are the top 3-5 skills requirements should this person have?

• CAD experience, Creo or solid works
• Plastic Design

What is a nice to have (but not required) regarding skills, requirements, experience, education, or certification?

• Tolerence analysis for dimensioning, product design prototying and testing experience