Details: TITLE: Verification & Validation EngineerEvery day Kelly Services connects professionals with opportunities to advance their careers. We currently have an exciting contract opportunity for a Verification & Validation Engineer at one of our top clients in Madison, WI.SummaryThis exciting opportunity is available for a person interested in Verification & Validation of life support products. Our group is a worldwide leader in the development of anesthesia and respiratory care products. We???re looking for team-oriented, energetic, curious, and passionate individuals to join one of our Verification & Validation teams. Work will include:??? Development, implementation, and documentation of new and current automated testing techniques.??? Validate systems and software through manual and automated test methods.??? Develop and carry out test plans. ??? Interface with other engineering disciplines to uncover and correct product non-conformances.??? Maintain and develop enhancements to existing test systems.??? Write test reports.??? Participate in project meetings/reviews.??? Contribute to continuous process improvement.Qualifications/Requirements:??? 4th year engineering student that has completed at least one co-op term; or 1 year experience in verification & validation in an engineering department; or 1 year experience in software development; or demonstrated problem solving skills in mechanical, electrical, software, and/or systems through 2 or more years of work experience. ??? Demonstrated communication skills, both written and verbal.??? Demonstrated leadership qualities and organizational skills. ??? Demonstrated ability to deal with high-paced dynamic environment while maintaining project agreements.Desired: ??? Bachelor???s or Master???s degree in Computer Engineering, Electrical Engineering, Computer Science, Biomedical Engineering. Bachelor???s or Master???s in a clinical discipline.??? 2 years C++/Java. ??? 1 year experience programming LabView.??? 2 years experience in validation work. ??? 1 year experience in the healthcare industry.??? 1 year experience in test system design work.??? 1+ years experience in computer networking In addition to working with the world???s most recognized and trusted name in staffing, Kelly employees can expect:- Competitive pay- Paid holidays- Year-end bonus program- Portable 401(k) plans- Recognition and incentive programs- Access to continuing education via the Kelly Learning CenterKelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world.Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the apply now button below to submit your resumes. If you have questions about the position, you may contact the recruiter recruiting for this position (916-773-2041 x210 or ), however, your resume must be received via the ???apply now??? button included within.We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide: www.kellyservices.com.Kelly Services???Celebrating 60 YearsKelly Services is an Equal Opportunity Employer
Details: One of the leading pharmaceutical companies in Massachusetts is in need of a Validation Engineer. If you have a degree in Chemical Engineering and background in cleaning validation process please send your resume to . All candidates must be able it interview this week.
Details: Hello, We currently have an excellent opportunity for a Validation Technician - Scientific. We are looking to bring this person in to a growing environment which will allow for room to grow not only financially but professionally as well. This is an immediate need so please return this with your latest resume and the best way/time to contact you so we can go over all the details. Best regards, Michael M 630-414-1637 Description Work on the daily activities Calibration and Maintenance Lab. Develop, deploy, and maintain calibration and test procedures that comply with all applicable standards and regulations. Maintain a calibration system that assures reliability, reproducibility and traceability to national or international standards for test and measurement equipment. Position is also responsible for the assistance in management of execution of projects and systems qualification of pharmaceutical/device manufacturing facilities, equipment, utilities and processes. Ensures compliance with regulations and proper GMP documentation. Bachelor’s Degree in Science, Engineering, or related field. 3-5 years of experience on Quality/Calibration/Metrology. Requires some scientific knowledge in the areas of manufacturing, laboratory testing, GMP documentation and regulations. Requires knowledge of repair and maintenance of equipment.
Details: Manager of Validation Manages activities of the manufacturing expansion and team validation activities. This includes project scheduling, tracking, and resource allocation in regards to Performance Qualifications for Equipment, Facility, Utility, Cleaning, Process, and Computer Validation studies. Establishes and implements Validation Programs to meet Regulatory requirements and provides QA oversight for the preparation and approval of Validation Master Plans, Project Plans, Protocols, and Final Reports. Interfaces with Manufacturing, Engineering, Utilities, QA, QC, and Regulatory agencies. n Role/s that report to this position: Validation Scientists Provides QA oversight for the preparation and approval of Validation Master Plans, Project Plans, Protocols, and Final Reports. Interfaces with Manufacturing, Engineering, Utilities, QA, QC, and Regulatory agencies. Serves as liaison with other CSL sites to assure harmonization with global validation practices. Implements and utilizes project management tools necessary to assure proper resource loading and allocation to meet project timelines. Participates in the interview and selection process for Validation project personnel. Assures that all Validation staff maintain training needs in compliance with existing site standards. Manages the preparation of study documentation packages, which include data, review, and a summary of each assessment for presentation to management and regulatory agencies, ensuring compliance with cGMPs. Maintains close contact with Manufacturing, Engineering, and the support labs to assure effective communication on problems and issues related to Validation. Coordinate the development and execution of Protocols. Assure adherence to site specific Policies, Plans, and Procedures.
Details: POSITION SUMMARYThe Validation Sr. Engineer/Supervisor reports directly to the Director of Technical Services and will perform specific assigned duties and undertake project work within the Process Technology Transfer and Validation Department. Ensures that company validation practices are compliant with cGMP regulations and meet industry standards.
Details: Mechanical Test Engineer II - Powertrain Validation - DIRECT HIRE2-6 Years of Relevant Work ExperienceBS in Engineering and/or PE LicensePAY RATE: $60-70K/YEARVolt has a Direct Hire position available in Mt. Vernon, WA for a Mechanical Test Engineer II.Position Description:Specifically, Our Client is seeking someone to develop test plans and conduct tests to validate Powertrain components, as well as meet Design and Performance requirements when installed in trucks.Essential Duties and Responsibilities:The Mechanical Test Engineer II:Plans, coordinates and conducts projects of moderate scope with minimal supervision.Analyzes project requests, discusses project requirements with Requestors, and formulates preliminary project plans, budgets and schedules.Designs fixtures and specifies instrumentation, equipment, vehicles, loading configurations, and data processing techniques.Participates in set-up of tests, verifies that test equipment and instrumentation equipment meet specified requirements, and performs preliminary data checks.Assembles resources required for testing; works to resolve resource conflicts.Participates in Data Collection and Analysis.Writes reports, as appropriate, incorporating results, conclusions and recommendations.Undertakes tasks on projects of significant scope; may undertake larger projects with appropriate supervision.Develops and improves test methodologies.May present results of test(s) or investigative projects to divisions or management personnel.Fosters good communication.Establishes and maintains cooperative and productive work relations with all other departments.Informs Managers, peers and division personnel of work progress, support, problems, scheduling conflicts, and/or opportunities of which they should be aware.This is a Direct Hire position in Mt. Vernon, WA, through Volt Engineering Services, headquartered in Seattle, WA. We are among the largest staffing companies in the US for contingent/temporary and direct hire placements, and support most of the top-rated companies in the Pacific Northwest.
Details: Kelly Scientific has an opening for a Method Development and Validation HPLC Chemist in the Orange County Area Long Term contract positionShift: M-F 8-5pmSalary: Negotiable DOE ESSENTIAL JOB DUTIES/RESPONSIBILTIES - Performing wet chemistry, HPLC, GC, Dissolution test, UV, PH. - Performing analytical tests of raw material, in-process, and finished products. - Calibrating instruments used for QC testing. - Documenting test results, problems and other issues, performing initial troubleshooting issues that arise during analysis, conducting all analysis and documentation using GMP and FDA guidelines. - Investigating OOS issues and implementing corrective actions. - Performing laboratory instrument validations (IQ, OQ, PQ). - Performing method validations, method research, writing protocols and method development - Performing cleaning validations. - Execute method validation protocols and write reports QUALIFICATIONS - BS Degree in Chemistry or related subject (MS or PhD highly preferred) - Minimum of seven (7) or more years of work experience performing analytical chemistry in a regulated industry (i.e. Pharmaceutical, Biopharmaceutical, and/or Nutraceutical) and work experience conducting validation (instrument, method, cleaning and process) and method development - Proficient use of the English language (verbal and written) - Excellent written and oral communication and presentation skills and techniques. - Effective planning & organizing skills. - Ability to handle multiple task/duties. - Knowledge and understanding of quality in a manufacturing environment, as well as laboratory controls and work safety rules/regulations. - Ability to execute validation protocols and reports. - Must know cGMP protocols and requirements for 21 CFR Part 111 or 211 best lab practices - Proficient math skills (addition, subtraction multiplication and division in all units of measures, using whole numbers, common fractions and decimals. - Ability to compute rate, ratio, percent and to draw and interpret bar graphs. - Ability to maintain a high-level of confidential information in the performance of job duties. - Ability to present information in one-on one and small group situations with customers, management, and other employees of the organization. - Ability to maintain a positive, professional, cooperative demeanor, conduct, and working relationship with peers, management and employees. - Ability to adapt effectively to workplace changes and new job duties/responsibilities. - Ability to represent the Company in a positive and professional manner at all times. - Effective trouble shooting, problem solving skills. - Willing to work late and/or during weekends; if needed. Interested applicants should apply directly below to the on-line resume builder link. To follow up interested candidates may call us at 714-971-0721.
Details: At Dr. Reddy’s, a global pharmaceutical company, you will contribute to making the breakthroughs of tomorrow a reality today! From making medicines more affordable to discovering innovative treatment options to satisfy unmet medical needs, we are dedicated to helping people lead longer and healthier lives. We are seeking dynamic and energetic individuals ready to inspire, ready to make a difference for their community and every community. Please Note: Unless an order has been placed with your agency for this role, we will not accept any calls or other inquiries from recruiters for this position. If a candidate is submitted despite this, we are not bound by any agreement terms and can hire the person as we see fit. Job Title: Validation Engineer Job Location: Shreveport, Louisiana• Provides on-going validation and revalidation of process improvements for manufacturing and packaging processes, equipment,and site facilities• Conducts and manages scale-up and technology transfers for new business opportunities• Writes and executes validation protocols for processing and packaging equipment, manufacturing processes, cleaning, and facility• Writes validation reports for process planning, development and implementation• Conducts statistic assessment for process validation and control• Provides scale-up and process knowledge for developing bids for new contract manufacturing and packaging• Trains personnel and writes procedures for new equipment and processes• Explores process improvement opportunities• Serves as the technical expert for various processes and or equipment• 10-20% travel required
Details: Job Title: Systems Validation EngineerJob Location : Chandler AZ 85226Job Discription : Develop, maintain and execute validation tests an automated LINUX environment. Debug test failures using logic analyzers and\or protocol analyzers to resolve functional issues within the silicon. Provide initial test failure debug using software debug tools. Read, understand and contribute to validation plans, architecture specifications and execution plans. Communicate effectively and regularly with the team to meet execution and production schedules. Identify improvements to the validation processTechnical qualifications include: Must have experience and excellent familiarity with C/C++ Must have experience with a scripting languages and writing scripts Must have experience in development and/or debug of programs on LINUX or UNIX operating systems Must have experience using Oscilloscopes, logic analyzers, and/or protocol analyzers Must have excellent written documentation and verbal communication skills Candidates should possess a Master’s degree in Engineering or a Bachelor’s degree in Engineering and five (5) years of related post-degree experience.
Details: Research Analyst – Ratings ValidationDenver, CO Charles Schwab has been a leader in financial services for nearly four decades, working to make investing more affordable, accessible and understandable to all. Driven by our purpose “to help everyone be financially fit”, we’re committed to building an environment that respects the diverse differences of our employees, our clients and the communities we serve.For more information about life at Schwab click here.Charles Schwab Investment Advisory, Inc. (CSIA) is a subsidiary of The Charles Schwab Corporation and an affiliate of Charles Schwab & Co., Inc. CSIA is responsible for managing Schwab Managed Portfolios, which are diversified portfolios comprised of either mutual funds or ETFs. Current assets under management are approximately $12 billion. CSIA performs the manager research and evaluation functions within Schwab's Managed Account Select platform, and also picks funds for Schwab's recommendable lists such as the Mutual Fund OneSource Select List. This growing team of approximately 25 investment professionals has diverse backgrounds which encompass quantitative financial research, investment manager due diligence, and portfolio management and trading.The Ratings Validation Analyst will have responsibility for ensuring the quality and accuracy of quantitative ratings for mutual funds, separately managed accounts and exchange-traded funds. The analyst will assist in building new validation tools as well as maintaining and using existing tools. Opportunities for other work such as the monitoring of funds used in Schwab Managed Portfolios will be available as well.Job ResponsibilitiesWork with business partners to produce mutual fund ratings and managed account ratingsDevelop tools to ensure the accuracy of ratingsMonitor funds used in Schwab Managed PortfoliosWork on ad hoc research projects in the mutual fund, ETF and separately managed account areasTechnical / Functional QualificationsBachelor’s degree required, preferably in Finance, Economics, Mathematics, Computer Science, or a related fieldExperience with basic computer programming required. Excel VBA a plus Excellent attention to detailProgress toward CFA charter desired, but not required
Details: Job Title: Systems Validation EngineerJob Location : Chandler AZ 85226Job Discription : Develop, maintain and execute validation tests an automated LINUX environment. Debug test failures using logic analyzers and\or protocol analyzers to resolve functional issues within the silicon. Provide initial test failure debug using software debug tools. Read, understand and contribute to validation plans, architecture specifications and execution plans. Communicate effectively and regularly with the team to meet execution and production schedules. Identify improvements to the validation processTechnical qualifications include: Must have experience and excellent familiarity with C/C++ Must have experience with a scripting languages and writing scripts Must have experience in development and/or debug of programs on LINUX or UNIX operating systems Must have experience using Oscilloscopes, logic analyzers, and/or protocol analyzers Must have excellent written documentation and verbal communication skills Candidates should possess a Master’s degree in Engineering or a Bachelor’s degree in Engineering and five (5) years of related post-degree experience.
Details: Our prestigious pharmaceutical client is hiring qualified senior validation engineers for their 6 months contract position. They have multiple openingsResponsibilities ?Maintains all documentation pertaining to cleaning cycle development and validation. ?Participates in cleaning cycle development activities for processing tanks including parameter selection, determining order of operations, troubleshooting, sampling, and data analysis. ?Coordinates validation execution between all involved departments. ?Independently follows-up and resolves comments, deviations, and technical issues. ?Authors development and validation protocols, SOPs, and reports. ?Reviews completed protocols for completeness, cGxP compliance and data acceptability; compiles final datapack. ?Reports progress and issues to team lead in an effective manner. Requirements ?Bachelor's degree or equivalent from accredited university in Engineering, Science, Computer Science, or technical discipline. ?5+ years of validation experience, with a strong emphasis in cleaning validation and cleaning cycle development. ?Knowledgeable in cGXP?s, validation principles, and change control. ?Proficient in the use of Microsoft Word, Excel, Visio and Outlook. ?Must be flexible to work all shifts, weekend work required. ?Experience with Kaye Validator instrumentation a plus. We are an equal employment opportunity employer.
Details: Title: Validation Scientist III,Duration: 11 + months (initially) with possible extensionLocation: Los Angeles, CA Job Description: The TA Validation Senior Scientist will be responsible for the process validation of new and currently marketed cosmetic, personal care and OTC Monograph drug products under our Client Beauty Franchise. This individual must have knowledge of the principles and approaches of product related process validation and will be responsible for providing hands on technical support to the Validation Manager in the design, development, and the implementation of validation studies meeting FDA requirements for products manufactured within the Client Los Angeles production facility. The validation program scope includes Semisolid (creams, gel and lotions) and Liquid products including OTC Monograph products. This individual will be accountable to the Validation Manager and responsible for assisting in the execution and maintenance of the Los Angeles facility process validation program and Validation Master Plan. The TA Validation Senior Scientist will provide hands on support and technical project management in the execution and maintenance of the validation program, including: study/protocol design, documentation, validation execution and process/cleaning revalidation activities. This individual is expected to be a resource within the manufacturing facility as it relates to validation activities and must have the ability to train personnel facility wide on validation requirements during the execution of the validation program. Validation documentation must be completed using good science and at a quality level that meets the established OTC Monograph, FDA, and Client Quality Compliance standards. This individual will work in a team environment with Operations/ Supply Chain, Quality Assurance, Technical Transfer, Analytical Development, Microbiology, Product Development and Regulatory personnel. This position reports into the Validation Manager, Technical Assurance. Qualifications: A minimum of a Bachelors degree with 6+ years of professional experience or a Masters degree with 4+ years of professional experience, or a PhD with 0-2 years of professional experience is required. A degree in Chemical Engineering/ Industrial Pharmacy or related field of study is preferred. Experience in process validation of OTC Monograph or NDA products within a FDA regulated production facility is required. Knowledge of the principals and approaches to validation and the FDA Validation Guidelines are required. Understanding of cGMP’s and current industry FDA Compliance requirements is required. Some knowledge of the validation of semisolid/liquid products and semisolid/liquid process technology is preferred. The candidate must be able to work independently with some supervision and have excellent oral and written communication skills. The candidate should have the ability to work collaboratively across functional groups in the execution of validation activities. This candidate must be a problem solver; detail oriented, and must be able to handle multiple responsibilities and projects. This candidate is expected to interact with team members, business and research partners across the manufacturing/business enterprise in accomplishing team project goals and objectives. This position may require minimal travel and is located in Los Angeles, California. A degree in Chemical Engineering/Industrial Pharmacy or related field of study is preferred. Experience in process validation of OTC Monograph or NDA products within a FDA regulated production facility is required. Knowledge of the principals and approaches to validation and the FDA Validation Guidelines are required. Understanding of cGMP’s and current industry FDA Compliance requirements is required. Candidate should be willing to do shift work (1st, 2nd and 3rd) and we can reduce years of experience to 3+ Bachelors degree and 2+ with a Masters with 0 required for a Ph.D.
Details: Wired Ethernet Validation Engineer The Wired Ethernet Validation Engineer is responsible for testing wired Ethernet software drivers with multiple operating systems including Linux and Microsoft Windows. Responsibilities include: - designing, writing and executing test cases, documenting test suites and test results, troubleshooting SW defects and entering information into a defect tracking database. - -working closely with software development engineers to resolve product quality issues.- developing new test methodologies and requirements, and coding of test scripts.- estimations of time and effort for project schedules, generating metrics and reports, forecasting equipment requirements, and placing testing results into a context which can be used for risk assessment. . This position requires significant interaction with other organizations including Engineering, Marketing, Customer Support, and Program Management. Additional duties may include screening, interviewing, recommending for hire, and directing the activities of Contingent Workers0Software Validation experience must be current with major releases of Microsoft Windows, and major distributions of Linux over wired Ethernet. The candidate should also have a minimum of 2 years current experience planning and validating advanced Ethernet features such ACPI/power management. Strong debug skills are required along with training or experience with test case/test plan creation, tracking and management. Strong working knowledge of networking protocols required, including but not limited to TCP/IP, and a working knowledge of Ethernet infrastructure equipment (hubs, routers, switches, cabling) including configuration and management. Programming and/or test automation and experience with other operating systems a strong plus.2+ of direct Ethernet testing, Mid-level or Sr.We're interested in an individual with either dual OS (i.e. Windows and Linux) knowledge or just Linux knowledge. Ideally they would be dual OS capable. Randstad Technologies is an EOE-M/F/V/D and is a wholly owned subsidiary of Randstad Holding nv, a $22.5 billion global provider of HR services and the second largest staffing organization in the world.