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Validation Power Content Development Engineer
Novus' customer is currently seeking a candidate for the position of System and CPU/SOC Power Validation Engineer. In this role you will work with a local and global team to understand, implement and verify the power features, power savings, power saving predictions, and performance of implementations of current and next-generation SoCs. You will create and execute test plans in both emulation and Post-Si environments, and work to discover, root-cause and correct failures in hardware and software. Additionally, you will create the software and flows which allow the maximum use of power saving features.
Candidate will have a minimum of 3 years of experience working in power estimate tools, emulation and silicon environments. Candidates are expected to have experience in:
-Emulation environments for hardware and software development and debug
-Familiarity with Power Estimate software such as Ansys, Cadence, and Primetime tools
-Analyzing power estimates, correlation, and power efficiency
-CPU and SoC architectures
-Strong C programming skills
-Strong understanding of power and performance features
-Understanding of silicon features such as isolation, clock gating, and power gating methodologies
-Basic understanding of debug
-Strong power background for pre and post silicon environments
-Strong Python/Perl scripting experience, including tool creation and flow automation
- Implementing bare-metal drivers and test content
-Experience in low level C drivers, micro kernel, RTOS, Linux, etc.
-Analyzing power data and drawing conclusions compared to pre-silicon
Required: Bachelor's, Electrical Engineering
Preferred: Master's, Electrical Engineering or equivalent experience
7829 Vlsi Lead Design Validation Verification
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Computer System Validation - Contract Position
Experience with computer system operations and information architectures while working in several different environments supporting FDA-regulated activities such as IT security and governance, system audits, and validation of software applications and documentation for enterprise applications.
- Ability to identify and recommend process improvement with the software development life cycle (SDLC).
- Ability to address 21 CFR Part II compliance issues, provide guidance on computer validation requirements of systems
- Ability to develop User Requirement Specifications for new and legacy equipment.
- Conduct validation risk assessments for software applications and equipment and make recommendations for remediation as needed.
- Assist in developing and reviewing artifacts as required for validation, including validation strategies and plans, validation protocols (IQ, OQ and PQ) and SOPs, Project Status Reports and Action Plans.
- Assist in the creation and execution of validation test scripts and documented test results in accordance with standards using both automated and manual tools.
- Serve as a quality consultant providing advice to departments on broader regulatory issues.
- Familiar with Oracle and SAP application development in various platforms
- Office Tools: Microsoft Office Suite 2007 (SharePoint, Word, Project, Visio, PowerPoint, Excel & Access)
- Familiar with Programming Languages: C++, JAVA, SQL
- FDA Regulations: cGMP and Regulated GxP Environments ( 21CFR Parts 11,210,211 and 820), USP 1058
- Familiar with HIPAA and FISMA Guidelines
- Computer System Validation (CSV)
- Methodologies: Software Development Lifecycle (SDLC), Agile and Waterfall models
- Audit Internal Control Frameworks: CoBIT and COSO, Sarbanes-Oxley (SOX sections 302 & 404)
- Electronic Document Management Systems (EDMS): Documentum v 6.x
- Automated and Manual Testing Tools: TestDirector / WinRunner, QTP and HP Quality Center v10.0
- Incident Management: TrackWise, Maximo, PVCS Tracker v5.0
- Laboratory Information Systems (LIMs): Sample Manager, HORIZON, Agilent ChemLMS; Chromatography Data Systems (CDS), Electronic Laboratory Notebooks (ELN)
IA Engineer - Navy Validator
About Seneca Resources:
Seneca Resources is client driven provider of strategic Information Technology consulting services and Workforce Solutions to government and industry. Seneca Resources is a leading IT services provider with offices in Reston, Virginia, Alabama and Columbia, Maryland that service clients throughout the United States. The key to our success lies within our strong corporate culture which drives our business. We challenge our staff through engaging work, and we reward our staff through competitive compensation, extensive professional training, and excellent opportunities for career advancement. In turn, we look for only the best and brightest to join our team.
We are an Equal Opportunity Employer and value the benefits of diversity in our workplace.
NCIS IA Engineer - Navy Validator
Clearance: Fully adjudicated active Top-Secret clearance is required to start, must be eligible to obtain SCI-level adjudication
Certifications: DoD 8570 - IAT Level II (ex. Security +)
The NCIS program is searching for a SeniorInformation Assurance Engineer (Navy-Intermediate Qualified Validator) to join their team in Quantico, VA.
- Designs, develops, engineers, and implements solutions that meet security requirements
- Responsible for the integration and implementation of computer system security solutions
- Performs risk analyses of computer systems and applications during all phases of the system development life cycle
- Identifies test requirements and tools based upon system designs
- Develops and reviews security test plans and procedures.
- Establishes and satisfies system-wide information security requirements based on analysis of user, policy, regulatory, and resource demands.
- Supports the Government Information Assurance (IA) Managers in the development and implementation of IA doctrine and policies.
- Initiates and prepares Certification and Accreditation (C&A) DoD Information Assurance Certification and Accreditation Process (DIACAP) and Assessment and Authorization (A&A) Risk Management Framework (RMF) packages; ensures existing C&A and A&A packages are maintained in a compliant status; verifies and validates C&A and A&A package requirements and configuration modifications are performed and tested.
- Reviews system engineering documentation, CONOPS, installation and configuration specifications to determine security requirements and to identify security concerns.
- Prepares briefing slides, status charts and support documentation as presentations for the client.
- Must have experience with using public key-based technologies for applications.
- 7+ years of experience working in the IT/Engineering field
- Must meet or exceed OPNAVINST 5239 requirements to be certified as Navy-Intermediate Qualified Validator
- Experience in the development of Certification and Accreditation plans
- Experience in Host Based Security Systems (HBSS), vulnerability scanning software and Information Assurance Vulnerability Alerts (IAVA).
- Experience in DIACAP and RMF, as well as the DIACAP to RMF migration.
- Trained and experienced using Assured Compliance Assessment System (ACAS), Enterprise Mission Assurance Support Service (eMASS)
- Completed Navy RMF training
- Fleet Cyber Command experience
Validation Engineers & Validation Specialists
Compli, LLC is a Validation and Regulatory Compliance Contract Services Provider dedicated to providing the Pharmaceutical, Biotechnology, and Medical Device Industries with high quality consulting services. We are currently looking for individuals to support our clients and projects throughout the United States.
We are interested in Validation Engineers/Specialists with experience in Commissioning, Qualification and Validation in the Life Sciences Industries (Pharmaceutical, API, Biotechnology, Medical Device and Diagnostics, veterinary and Cosmetics product manufacturing operations) specific to facilities, utilities, equipment, computer-related systems, analytical equipment, cleaning validation, analytical methods validation and process validation. C
The successful candidate should meet the following requirements:
• Must be able to develop, execute, and write commissioning and validation protocols and summary reports.
• Possess strong computer skills, technical writing skills, as well as good communication skills.
• Bachelor’s degree in Science or Engineering, or equivalent related experience required.
Compli offers a competitive benefit and compensation package. You will be given the opportunity for personal and career growth in a company that places a high value on the contributions of its employees.
Computer Systems Validation Engineer
Qualifications (Education and years of experience):
Bachelor’s degree in Mechanic/Electrical/Chemistry/Computer Engineering preferred and minimum 3 years of experience
· CSV system development life cycle is required. Thorough knowledge of cGMP regulations related to CSV including 21 CFR Part 11 is required. Strong knowledge of system development life cycle is required. Knowledge/familiarity with U.S. and Global regulatory registration of drug products is preferred. Strong leadership skills and the ability to work in cross-functional team environments, as well as independently, and to manage multiple and competing projects are required.
Experience and Description of Position:
The purpose of this role is to develop and conduct appropriate procedures regarding the Qualification and Validation of company equipment, processes, Software and systems. Responsible for the development and execution of computer and/or automation systems validation in compliance with current Good Manufacturing Practices (cGMPs) and all other regulatory and/or guidance requirements such as Annex 11, GAMP and 21 CFR Part 11.
Preferred qualifications/Desired Skills :
· Development of computer and automation systems validation ensuring compliance to required regulatory requirements.
· Support activities include, but are not limited to, SOP creation, documentation generation, review and approval.
· Activities also include change controls, assessment plans, risk assessment reports, compliance plans, user requirements, system and user acceptance testing protocols, traceability matrix, error reports/defect report forms and summary reports.
· Compiles and analyses validation data and makes recommendations for changes and/or improvements.
· May also investigate and trouble-shoot problems which occur and determine solutions.
· Maintains all documentation pertaining to computer systems validation.
· Participates on cross-functional project teams with the support of Development, Manufacturing, Engineering, Quality, and other groups.
· Experience with Manufacturing and Packaging Equipment/Systems.
This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications
Lead Validation Engineer
The holder of this position is charged with leading effort to prove control of the critical aspects of company operations, whether these relate to process, cleaning, equipment, utilities, computers or other elements.
- SUBJECT MATTER EXPERT in AT LEAST TWO MAIN area of validation ( Process/Cleaning/Equipment /Utilities /Facilities/Computer Systems)
- Lead and structure scientific debate and assessment with peers from other technical areas to develop scientific understanding
- Determine levels of importance or risk to be assigned to elements under review using scientific rationale to justify scale of effort.
- Demand / extract appropriate definition of science underpinning element (product, process, equipment, cleaning regime) under review
- Link all efforts to the patient
- Present a coherent and clear picture of validation effort to any reviewer or auditor, providing confidence in the installed equipment, process, equipment, facility or procedure
- Understand the science and areas of technical knowledge that underpin area of focus & must be able to apply this knowledge in the development of validation approach and in the presentation, documentation & review of outcome
- (As required) Move to others areas of activity applying skills in logic and scientific method while quickly assimilating knowledge and contributing to delivery
- Represent the validation group (i.e. in certain forums position holder will be the sole representative of the Validation department, in such circumstances the validation scientist should be prepared to answer for the whole group and/or where unable to do so immediately should take ownership for timely follow-up actions)
- Contribute to validation policies, guidance documents (SOPs, VMPs, VPPs) detailing best practice approach
- Understand best industry practice, current developments and opportunities arising for company
- Present to potential clients on why validation approach in the company provides both assurance of a safe pair of hands (compliance and adequacy of transferred process) and is effective (time & cost)
- Actively participate in Professional/Industry groups to learn, to influence and to represent the company
- Much of the validation Department activity is concerned with maintenance of GMP compliance through monitoring, review, assessment and qualification of activities. The holder of the position will be required to contribute effectively in these areas. Contribution in areas such as change control, PPIs, APRs, and PRs, VMPs and SOP updates will be required as well as attendance in forums such as PRB and KPI reviews (see above with regard to representation)
Ensure Validation systems (policies, procedures, reviews, VMPs, etc.) meet current / changing industry demands and that they do so effectively. The holder of this position is also responsible for the maintenance of these validation systems and ensuring compliance of Validation corrective actions.
Bachelors Degree in a Science or Engineering discipline with 5-8 years relevant experience.
- Experience using
Val-genesis Software a plus
- Must be computer literate.
- Must be (or quickly become) familiar with Regulatory requirements and guidance applicable in area(s) of deployment.
Lead Validation Engineer-Computer Systems
This position provides technical leadership and accountability for computer system validation and ensures compliance with internal and external computerized system policies and regulations. As the Subject Matter Expert, this individual will ensure sites are fundamentally aware of and proactively implement current computerized system validation practices with particular focus on impact to patient safety, product quality and record integrity. Position scope includes local and global site systems as well as SaaS (Software as a Service) solutions.
ESSENTIAL AREAS OF RESPONSIBILITY:
_Computer System Validation _
- Lead computer system validation for local and global sites including automated lab equipment software, data tracking and trending software, quality systems software and associated business system interfaces.
- Determine computer system validation strategy for system qualification in alignment with company systems and collaborate/lead in decision-making and make recommendations regarding best options.
- Communicate proactively with stakeholders and management regarding progress, issues and plans for resolution and to ensure the project team and/or network is fully informed of updates and improvements.
- Develop computer system validation related content; controlled documents to support the start-up, validation, operation and maintenance of site GMP computerized systems, for project qualification plans and protocols.
- Monitor/support on-going computer compliance and perform periodic system reviews ensuring that the systems maintain their validated status.
_Policy Writing and Revision _
- Ensure the site(s) are compliant with current corporate global computerized validation policies and legislative requirements by setting and maintaining computerized system validation standards via computerized system validation SOPs.
- Author, review or approve the Validation Plans, Computer Validation Protocols and Reports and associated Validation Reports.
- Ensure all centrally produced tools, templates and materials are available and relevant to site.
_Internal, Partner, and Regulatory Audit Support _
- Support Regulatory inspections and internal and partner audits, and implement corrective actions as needed. Provide Computer System Validation related responses to inspectors/auditors.
Project and Budget Management
- Ensure resources including key personnel, training and experience is in place before beginning computerized system validation activities.
- Measure and report project execution progress.
Risk Assessment Activities
- Ensure that the computer system validation efforts are directed at the systems that have the potential to impact product quality, efficacy and data integrity using a variety of tools including GAMP 5.
MINIMUM EDUCATION & EXPERIENCE REQUIREMENTS:
BS degree in a technical or scientific discipline including Engineering or Computer Science. Minimum of five (5) years in the pharmaceutical industry with GMP experience and expertise as a practicing professional in the area of computer system validation. Ten (10) years preferable.
TECHNICAL KNOWLEDGE/SKILLS NEEDED:
- Areas of expertise include validation of cGMP computerized systems within an FDA regulated environment.
- Comprehensive knowledge of Validation lifecycles for site and global systems (i.e., IT, Analytical Equipment, Spreadsheets, SaaS (Software as a Service), Oracle, Trackwise, Maximo)
- Practical experience with quality risk management and risk based validation approaches.
- Thorough understanding of industry standards and best practices computer system validation such as GAMP 5 and ASTM E2500.
- Knowledge of cGMP regulations and guidelines including but not limited to U.S. Code of Federal Regulations 21 CFR Part 11 and Part 211, EudraLex Volume 4 and Annex 11, and ICH Q7, Q8, Q9 and Q10.
- Demonstrated Project Management abilities to lead and manage a high volume of simultaneous projects.
- Excellent written and verbal communications, including technical writing. Microsoft Office Software, with MS Project.
Validation Analyst- Csv/Gmp
Client seeking Validation Analyst for a 6 months, temp to perm possible. First shift. Must sit onsite Middleton, WI office. No relocation provided. GMP/Regulated lab, CSV experience required. Computer Science degree is preferred.
Title: Validation Analyst
Middleton, WI, United States
Performs validation of computer-based laboratory instrument systems and software in a GMP environment. Coordinates and executes the IQ/OQ/PQ activities for assigned systems. Facilitates the validation process as well as implementation of system upgrades, including duties of guiding, testing, supporting the introduction, and ongoing support of software systems. Participates as a member of the Project teams where needed and help provide direction on future enhancements to the system.
Education and Experience:
Requires 4-yr degree in computer, biological or life sciences or related area, or equivalent combination of education, training and professional experience that provides the required knowledge, skills and abilities
2 years experience in the validation of computer-based laboratory instrument systems in a GMP regulated environment
Knowledge, Skills and Abilities:
Client focused approach with strong interpersonal skills.
Strong oral and written communication skills and ability to teach others.
Strong attention to detail and problem solving skills.
Competent with MS Word, MS Excel, MS PowerPoint, MS Project.
Demonstrates positive attitude, enthusiasm toward work and the ability to work well with others.
Good organization skills and time management skills with the ability to adapt and adjust to changing priorities and to manage multiple
assignments with challenging/conflicting deadlines.
Good understanding of software development life cycle (SDLC).
Proven ability to learn new computer software with minimum of instruction.
Strong troubleshooting skills needed to analyze software defects and the ability to explain how errors are produced.
Ability to attain, maintain and apply a working knowledge of applicable SOPs/WPDs
Software Test Validation Manager (344)
SOFTWARE TEST VALIDATION MANAGER
Launched in 1987, USDI is celebrating its 30th anniversary of Engineering Excellence and Operational Efficiency. We provide our diverse clients with customized solutions to fit their needs and we offer our team members a challenging and supportive internal culture to be a part of.
At this time, we would like to strengthen our team by hiring an industry experienced and knowledgeable Software Test Validation Manager.
If you are looking to continue to enrich your career growth, continue to think outside the box, and be part of a growing, cutting edge team, then USDI is the place for you.
The Software Test Validation Manager will lead a team of Software Applications Engineers in their endeavors to develop State of the Art of Embedded Software Applications and processes for Battery Management Systems (BMS).
As part of his/her daily tasks, the Software Test Validation Manager shall be able to provide guidance, technical and functional support mechanism to the software team, in addition to interfacing with Program Managers and other team leaders to provide the software engineering resources needed to support the ongoing software design and development activities.
- Plan and monitor Resource Allocation, Projects Load distributions to support concurrent development projects.
- Strengthening the use of Project Management best practices across multiple projects.
- Support SW Leads in working with Project Managers to develop and monitor plans to meet project milestones
- Encourage the full utilization of Continuous Improvement of established software development processes and best practices to ensure that software quality expectations are fulfilled.
- Monitor software Projects Development Life Cycle to insure full compliance with Programs SOW and Statement of Thresholds.
- Provide weekly status reports and updates covering project life cycle development status, software quality assurance measures, and risks assessments.
- Set appropriate corporate software development standards by communicating projects assignment expectations; providing yearly goal setting to various team members, conducting performance reviews; planning, monitoring, and appraising job results; coaching, and counseling.
- Collaborating with HR Team, to create & maintain training, support continuous educational/academic plans, as well as define orientation plans for newly hired Software Engineers.
- B.S. in Electrical or Software Engineering, or equivalent/relevant education
- Advanced understanding of software engineering practices and process maturity models, e.g. Automotive SPICE.
- Software design and programming experience in embedded C, and embedded applications.
- Experience working with Global Suppliers.
- Exceptional written and verbal communication skills.
- Ability to interface well with internal and external customers.
- Demonstrated experience building teams and managing multiple projects in parallel
- Ability to consult, train and coach engineers.
- Some experience with battery and/or power management systems
- Experience with Off Shore development teams across multiple time zones
- Requirements Management and analysis experience
- Experience developing software for Tier 1 Automotive Supplier
- Familiarity with the ISO26262 Functional Safety Standard
- Some experience with Model-Based Development tools and processes
USDI has a very generous benefit package including Medical Insurance, Life Insurance and Retirement Savings program. We also offer generous reimbursement programs for Optical and Dental expenses. Above all, we pride ourseves in offering a support staff that helps each team member achieve their personal career goals and objectives to the best of our ability!