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Senior Validation Engineer - Biotech Equipment Installations (3154)


Job Title:
Senior Validation Engineer – Equipment Installations  (JP3154)


Location:
Louisville, KY

Employment Type: Contract
Duration: 1+ Years
3Key Consulting Inc., one of Southern California’s largest life-sciences staffing firms is looking for role for a Sr. Validation Engineer with experience in equipment installations within highly regulated biotech environment for a global, CA-based, bio-pharmaceutical company.

Job Description:

Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment. Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects following corporate standards and procedures. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity. 

  • Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
  • Develop engineering policies and procedures that affect multiple organizational units.
  • Supervise, coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
  • Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
  • Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
  • Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
  • Application of mature engineering knowledge in planning and conducting projects.
  • Prompt and regular attendance to workplace
  • Other functions may be assigned 
Top 3 Must-Have Skill Sets:
  • Familiarity with validation processes and documentation in a highly regulated environment
  • In-depth knowledge of validation processes and requirements as applied to new equipment installations
  • Management of contractors.
Red Flags
Resources with educational background lower than bachelor's degree'
Day-to-Day
Responsibilities:
  • Develop technical solutions to complex problems requiring the regular use of ingenuity and creativity.
  • Work with research, manufacturing, process development, utilities, facilities, quality assurance and validation departments in developing requirements and recommendations for large and/or highly complex system/facility modifications.
  • Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
  • Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
  • Develop departmental budgets or project budgets encompassing multiple disciplines for area within project or entirety of smaller project. 
Employee Value Proposition:
Gain experience in large biotech firm.
Why This Position Is Open:
Additional support needed for team projects
Interview process:
Two phone interviews, 1-hour each beginning on the week of May 30, 2017
We invite qualified candidates to send your resume to resumes @3keyconsulting.com.
If you decide that you’re not interested in pursuing this particular position, please feel free to take a look at the other positions on our website www.3keyconsulting.com. You are also welcome to share this posting with anyone you think might be interested in applying for this role.

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Validation Engineer

Description
The potential candidate for the Validation Engineering position must posses experience in the pharmaceutical, Medical Devices or Biotechnology GMP environment with  Equipment Qualification,CSV, Packaging Validation and Statistical Knowledge.
Duties and Responsibilities
  • Must possess a solid understanding of FDA Validation guidelines and industry best practice for this field; and be able to implement Validation standards on a daily basis
  • Implements policies and procedures to validate/qualify equipment, CSV, and processes in accordance with regulatory requirements and company manufacturing standards
  • Generates, executes, reviews, and complete qualification and validation protocols, summary reports and associated data for conformance to regulations, SOPs, specifications and other applicable acceptance criteria.
  • Works with The Complete CSV Validation Cicle.
  • Prepares, coordinate and execute qualification activities
  • Solid Dosage Validation Experience
  • Solid Dosage Equipment Validation 
  • Coating Manufacturing Process Experience
  • Packaging and Manufacturing Validation Equipment.
  • Communicate with the staff and management on ways of implementing plans and recommendations.
Requirements
  • CSV experience
  • Vision systems experience (Cognex)
  • Be able to sense needs when they arise.
  • Be organized
  • Solid Dosage experience
  • Attention to details.
  • Strong interpersonal skills and team oriented
  • Fully Bilingual (English and Spanish, verbal and writen)
Education
  • 3-5 Year of experience with Validation for Manufacturing and packaging equipment. 
  • Bachelor Degree in Engineering Field.

Ultimate Solutions Corp. is an Equal Opportunity Employer

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Mixed Signal Validation Engineer

Mixed Signal Validation Engineer
Our Company’s team is looking for a Mixed Signal Validation Engineer with strong silicon validation and problem solving skills to join our growing team. In this role, the Mixed Signal Validation Engineer will be a key contributor by understanding the systems our products go in and validating that our products meet these system requirements.
Mixed Signal Validation Engineer Roles and
Responsibilities:

  • Development of lab validation infrastructure used in silicon validation
  • Definition and carrying out of experiments targeted at items in our emulation and validation plans
  • Debug and troubleshooting lab setup issues
  • Creating and updating bug incidents
  • Creating both detailed and summarized lab validation results Skills and Experience:
    1. Strong fundamental skills in the analysis of board level analog and digital circuits
    2. Ability to learn and code routines in Matlab, LabView, Python, and C++
    3. Problem solving skills applicable to board level, lab equipment, and software issues
    4. Basic skills in statistical analysis
    5. Basic understanding of SQL databases
    6. Very strong skills and experience using oscilloscopes, multi-meters, and frequency domain signal analyzers Nice to Have Skills
    7. Ability to program and use FPGAs and/or uC
    8. Ability to architect lab validation bench setups and corresponding software environment Education Requirements
Mixed Signal Validation Engineer
Job Requirements:
  • BS or MS in Electrical or Computer Engineering
  • 2 years experience in an application or validation engineering role
  • Excellent communication skills and able to work in a fast-pace team environment
  • Willingness to Travel - Occasionally

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Lead And Validation Investigator - US Telecommute

Position Description:

Energize your career with one of Healthcare's fastest growing companies.

You dream of a great career with a great company - where you can make an impact and help people. We dream of giving you the opportunity to do just this. And with the incredible growth of our business, it's a dream that definitely can come true. Already one of the world's leading Healthcare companies, UnitedHealth Group is restlessly pursuing new ways to operate our service centers, improve our service levels and help people lead healthier lives. We live for the opportunity to make a difference and right now, we are living it up.

This opportunity is with one of our most exciting business areas: Optum - a growing part of our family of companies that make UnitedHealth Group a Fortune 17 leader.

Optum helps nearly 60 million Americans live their lives to the fullest by educating them about their symptoms, conditions and treatments; helping them to navigate the system, finance their healthcare needs and stay on track with their health goals. No other business touches so many lives in such a positive way. And we do it all with every action focused on our shared values of Integrity, Compassion, Relationships, Innovation & Performance.

The Lead and Validation Investigator will have the following responsibilities.

Primary Responsibilities:

  • Identify aberrant billing patterns and trends via data analysis and research

  • Identify viable flag prospects for clients

  • Manage SBM requests specific to tips / referrals submitted by the Operations Team (i.e. Provider Education referrals)

  • Maintain and manage flag documentation and activity for multiple clients

  • Develop presentation decks for Client Meeting

  • Pull Provider Summary Reports

  • Ability to request detailed report data from Analytic partners

  • Work with less structured, more complex issues

  • Serve as a resource to others

  • Generally work is self-directed and not prescribed

Required Qualifications:

  • High School Diploma / GED (or higher)

  • 2+ years of Investigational / Auditing experience

  • 2+ years of Health Care Claims experience

  • Advanced Microsoft Excel skills (pivot tables, sort / filter, formulas)

  • Basic Microsoft PowerPoint skills (creating presentations)

  • Strong Data Analysis skills

  • Ability to travel up to 5% of the time

  • Ability to work an 8 hour shift between 7:00 am - 5:00 pm

Preferred Qualifications:

  • Bachelor's Degree (or higher)
  • Certified Fraud Examiner (CFE)

Soft Skills:

  • Analytical Problem Solving Skills

Careers with Optum. Here's the idea. We built an entire organization around one giant objective; make the health system work better for everyone. So, when it comes to how we use the world's large accumulation of health-related information, or guide health and lifestyle choices or manage pharmacy benefits for millions, our first goal is to leap beyond the status quo and uncover new ways to serve. Optum, part of the UnitedHealth Group family of businesses, brings together some of the greatest minds and most advanced ideas on where health care has to go in order to reach its fullest potential. For you, that means working on high performance teams against sophisticated challenges that matter. Optum, incredible ideas in one incredible company and a singular opportunity to do your life's best work.

Diversity creates a healthier atmosphere: UnitedHealth Group is an Equal Employment Opportunity / Affirmative Action employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, protected veteran status, disability status, sexual orientation, gender identity or expression, marital status, genetic information, or any other characteristic protected by law.

UnitedHealth Group is a drug-free workplace. Candidates are required to pass a drug test before beginning employment.

Keywords: Lead, investigation, fraud, data analysis, claims, Optum, UHG


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Common Market Mid Atlantic Delivery Jumper

The Common Market Mid-Atlantic, a mission-driven distributor of local foods to the Philly/ Baltimore/ DC region seeks a Jumper to assist a Driver in making refrigerated food deliveries to public schools in Philadelphia. This is a full time position with hours of approx 7am-3pm M-F.
Our mission is to strengthen regional farms while making the local bounty accessible to communities and the institutions that serve them. Our trucking team is responsible for front-line service to our customers, transporting and handling perishable products.
Main Responsibilities
- Provide excellent service while delivering refrigerated food
- Assist in loading and unloading truck manually

- Make deliveries with a hand truck. Some deliveries have elevators, others are taken up and down stairs
- Guard Food Safety and Quality
- Know food safety rules, check and document safe conditions
- Begin and end each truck run with established procedures
- Communicate all pickups, deliveries, and service issues with CM office.

Requirements

1. Child abuse clearances
2. Excellent verbal and written communication skills in English
3. Ability to be on feet for full 8-10 hour shift, and to lift up to 55 pounds
4. Flexibility, a sense of humor, and a strong desire to learn
5. Experience using computers

6. Ability to work well with the same driver 5 days a week

Benefits

Common Market offers an excellent work environment, training and the chance to grow with our organization.
Wage: $12, with the ability to earn raises quarterly
Benefits:

5 Paid days off per year

Monthly health care stipend of $360

Please no phone inquiries

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Computer Systems Validation Engineer

Job Description

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

Company Description

mirus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the involved project management.

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Validation Engineer

Candidates with the following experiences are preferred: - Silicon bring-up and functional validation- Using lab equipment- Basic debug skills to isolate issues between HW & SW, modules, and devices- Knowledge of PVT, TCU, Fmax, Vmin, etc

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Staff Product Validation Engineer

Responsibilities

As a System Validation Design Engineer, you will be involved in designing, building and debugging system level hardware, firmware, drivers and software to test leading edge Integrated Circuits in their intended applications. Design work includes:

  • Test Automation via in house tools using Java, BeanShell & Shell scripts.
  • Linux and Windows Storage Driver development in C.
  • Develop, execute and document a subset of the suite of tests that will fully validate the operation of the SOC solution design. Tests will cover areas such as:

  • Basic Functions

  • Advanced Feature Functions
  • Solutions
  • Performance
  • Error Injection
  • Multi OS support
  • Interoperability
  • Scalability
  • Troubleshoot and resolve complex problems in embedded multi-core real-time systems.
  • Utilize state of the art logic analysis and protocol analyzers.
  • Utilization of test and defect tracking tools to document and report on validation progress and product quality.
  • Creation & management of system validation testing schedules and their execution.
  • Isolation and resolution of complex software & firmware problems in embedded real-time systems.
  • Effectively present technical information to small teams of engineers.

  • BS/MS Electrical/Electronic Engineering, Computer Science, or Computer Engineering.

  • 5+ years of validation and testing experience in software/firmware/driver/systems, ideally in storage
  • Experience/Knowledge of Java/C programming languages and at least one shell scripting language (Python/ Linux Shell/BeanShell)
  • Knowledge of key components of a server and storage solution
  • Strong problem solving skills, communications and interpersonal skills are required
  • Ability to quickly learn new technologies
  • Excellent analytical and documentation skills

DESIRED

  • Experience working in Linux and Windows Environments and file system structures
  • Experience with RAID, HBA's, SAS Controllers and their associated Software Testing Strategies
  • Experience in storage protocol validation (SAS, SATA, NVMe)
  • Experience with protocol analyzers and error injection tools. (Lecroy, Finisar, Quarch)
  • Experience with Storage IO Generators (IOMeter, Medusa, FIO)
  • Experience troubleshooting server system hardware and networking infrastructure to root cause issues
  • Experience working with cloud based storage such as Ceph, Swift or Cinder
  • Knowledge of host driver architectures in Windows and Unix
  • Highly motivated, sets personal goals, and achieves goals without supervision

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Driver Training Program - Full Time (Must Have A Valid Class A): Jolie

Overview: YRC Worldwide is an Equal Opportunity/Affirmative Action Employer Minorities/Females/Persons with Disabilities/Protected Veterans Click here to view EEO is the Law Responsibilities:

Come discover your direction at Holland! Holland, Inc,. is a recognized leader in next-day delivery, quality handling, and on-time performance in the LTL industry. If you have your Class A CDL, but may not have the experience and/or the required endorsements to be a Holland driver then you may be interested in our Driver Training Program offered at our Joliet, IL terminal.

The Driver Training Program allows you to work on the dock while you get your Hazmat/Tanker endorsements or work with a driver mentor to gain the skills necessary to become a full time driver with Holland. We have both Local and Regionals positions available. Local drivers are home daily and Regional drivers are home every week.

This is a great opportunity that offers great pay and benefits for drivers who recently graduated from driving school, who may not have experience driving our type of equipment, who may not have driven recently, or are missing either their Hazmat and/or Tanker endorsements. Responsibilities : To safely and efficiently operate commercial motor vehicles in urban, suburban, and rural areas in all weather conditions to transport freight. Load, unload, and move materials at customer location.

Comply with company policies and federal, state and local regulations Follow company procedures for safely loading and unloading freight Take and verify dispatch instructions Operate a tractor-trailer combination (vans) Load and unload freight in varying weather conditions at the company and customer facilities Safe operation of equipment and on-time movement of shipments Conduct pre-trip and post-trip inspections Maintain truck log according to state and federal regulations Full- time driver benefits include: Company paid Health Insurance Vacation, Holiday and Sick pay Over Time by the day (over 8 hrs) Pension Benefits Direct Deposit 5% Wage Increase after 1 year, 2 years, and 3 years Cost of living increases are included in contract Qualifications: Drivers Training Candidates should have : Valid Class A CDL No major accidents in the last 3 years No DUI/DWI in the last 3 years Qualified applicants will be required to take a pre-employment drug screen with true negative results and required to take additional pre-employment testing/assessments #CB#



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Test And Validation Engineer (210)

Job Description

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 experiences and knowledgeable Test and Validation Engineer.

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.

Position
Overview:

Reports to: DV Test Engineering Manager

Responsible for the development and execution of Li-Ion Battery Electronics/Module/Pack test related activities including Design Verification and Process Validation.

Primary
Responsibilities:

· Plan, schedule, and execute test plans for all levels of product testing, including DV/PV.

· Analyze, document and publish test reports to support test plans and product delivery. Have total ownership of the overall test plan and test results.

· Interface with outside test houses/vendors to perform required testing, including quoting and scheduling.

· Determine requirements for new test equipment and / or redesign of existing test equipment.

· Recommend, purchase and implement equipment, instruments, data acquisition, etc., required for all levels of product testing including the design of test fixtures and testing instructions.

· Develop and implement software and/or scripts for new or existing test equipment.

· Ensure all product issues are identified, logged, tracked and resolved during each testing phase.

· Assists in the review of test processes as they are developed.

· Provide detailed field data and internal test reports to supply feedback to engineering on needed improvements and any product failures in the field.

Specific Skills/Abilities:

· Familiarity with environmental, mechanical, and electrical verification testing methodologies in an automotive environment.

· Familiarity with vehicle Controller Area Network (CAN) communication interface.

· Familiarity with Vector CANoe/CANanlyzer

· Ability to replicate problems to determine its type/nature and communicate this to engineering to help resolve design issues.

· Previous experience with specification and integration of data acquisition using various test instrumentation required.

· Experience with DIAdem or other data analysis tools a plus.

· Experience with high voltage EV/HEV battery systems a plus

· Software programming experience is a plus.

· Ability and willingness to work on multiple projects at one time and be able to adapt to changing priorities.

· Excellent analytical and interpersonal skills.

· Excellent communication skills, both in written and oral format.

Education/Experience:

· Bachelor’s Degree in Electrical/Mechanical Engineering.

· Minimum 5 years relevant experience in Design Verification/Process Validation testing

Company Description

USDI was founded in Michigan in 1987 with a goal of providing fast-to-market technical engineering solutions to a variety of industries and also providing individuals excellent career opportunities, training, and support. Our engineers complete the projects that are not the mainstream business of our customers or the projects that require more resources than the customer has on staff. Our clients leverage USDI training and experience to save development time and money. We pride ourselves on having a team of unique individuals that excel in their own area of expertise, and our customers have come to expect that from us.
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!

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