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Added 1 min ago
Engineer II, Software Assurance, Product Security (Remote)
CrowdStrike
Juneau, AK
Experience working in an engineering role implementing, supporting, and monitoring software security systems.
Added 3 mins ago
Engineer II, Google Cloud
PWC US
IL-Chicago, IL · NC-Raleigh, NC · NC-Charlotte, NC · OH-Cincinnati, OH · OH-Cleveland, OH · SC-Columbia, SC · OH-Columbus, OH · TX-Dallas, TX · VA-Richmond, VA · MD-Baltimore, MD · NY-Rochester, NY · IL-Rosemont, IL · CA-Sacramento, CA · MA-Boston, MA · MO-St. Louis, MO · UT-Salt Lake City, UT · TX-San Antonio, TX · CA-San Diego, CA · CA-San Francisco, CA · CA-Silicon Valley, CA · WA-Seattle, WA · SC-Spartanburg, SC · NY-Albany, NY · CT-Stamford, CT · FL-Tampa, FL · GA-Atlanta, GA · OH-Toledo, OH · OK-Tulsa, OK · TX-Austin, TX · DC-Washington, DC · CO-Denver, CO · IA-Des Moines, IA · FL-Boca Raton, FL · MI-Detroit, MI · NY-Buffalo, NY · NJ-Florham Park, NJ · TX-Fort Worth, TX · NC-Greensboro, NC · CT-Hartford, CT · TX-Houston, TX · IN-Indianapolis, IN · MI-Grand Rapids, MI · CA-Irvine, CA · FL-Jacksonville, FL · MO-Kansas City, MO · NV-Las Vegas, NV · AR-Little Rock, AR · CA-Los Angeles, CA · KY-Louisville, KY · AL-Birmingham, AL · AR-Fayetteville, AR · NY-Melville, NY · FL-Miami, FL · WI-Milwaukee, WI · MN-Minneapolis, MN · VT-Montpelier, VT · TN-Nashville, TN · LA-New Orleans, LA · NY-New York, NY · OK-Oklahoma City, OK · FL-Orlando, FL · PA-Philadelphia, PA · AZ-Phoenix, AZ · PA-Pittsburgh, PA · OR-Portland, OR
…applications on Google Cloud, supporting work across the full software development lifecycle from new product ideas to modernization efforts. As an Associate you will learn through hands-on…
Added 8 mins ago
Data Engineer
K2 Space
Los Angeles, CA
Our enterprise software team builds the digital backbone that powers K2 Space’s satellite design, manufacturing, and mission operations. We develop tools that connect engineering,…
Added 10 mins ago
U
Software Engineer II - Web Engineer
Uber
San Francisco, CA · New York City, NY · Sunnyvale, CA
- $171,000 to $190,000 USD / year
3+ years work experience in software engineering building large scale systems
Added 10 mins ago
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Software Engineer II - Backend Engineer
Uber
San Francisco, CA
- $171,000 to $190,000 USD / year
Contribute to design reviews, code quality, observability, and engineering practices.
Added 10 mins ago
U
Software Engineer II - Backend Engineer
Uber
New York City, NY · San Francisco, CA · Sunnyvale, CA
- $171,000 to $190,000 USD / year
3+ years work experience in software engineering building large scale systems
Added 17 mins ago
Security Engineer II, AWS Vulnerability Management, Third Party Software
Amazon.com Services LLC
Austin, TX
A Security Engineer at Amazon is expected to be strong in their security domain, for this role it's third party software and open source vulnerability management, and provide contributions…
Added 31 mins ago
Product Manager
STARLIMS Corporation
Remote, United States
…needs and usage data into prioritized, well-defined work for Engineering, runs the backlog and releases with discipline, and is accountable for adoption and customer satisfaction in the…
Added 35 mins ago
CLE ATC Training Materials Administrator-II
SAIC
Cleveland, OH
SAIC is a premier technology integrator, solving our nation's most complex modernization and systems engineering challenges across the defense, space, federal civilian, and intelligence…
Added 36 mins ago
Field Service Engineer II
ROTARY COMPRESSION TECHNOLOGIES INC.
Cincinnati, OH
Added 36 mins ago
Lead Engineer
Fiserv
Columbus, OH
At Fiserv, we are dedicated to transforming financial services technology to benefit our clients. As a Software Development Engineering - Advisor II, you will play a critical role in…
Added 51 mins ago
Senior Program Manager (SCA)
Serco USA
Andrews AFB, MD · Aurora Buckley AFB, CO · Cannon AFB, NM · Columbus AFB, MS · Dyess AFB, TX · Edwards AFB, CA · Eglin AFB, FL · Eielson AFB, AK · Ellsworth AFB, SD · Fairchild AFB, WA · Glendale Luke AFB, AZ · Goodfellow AFB, TX · Grand Forks AFB, ND · Hanscom AFB, MA · Hill AFB, UT · Kirtland AFB, NM · Langley AFB, VA · Laughlin AFB, TX · Little Rock AFB, AR · Maslmstrom AFB, MT · Maxwell AFB-Gunter Annex, AL · McConnell AFB, KS · Minot AFB, ND · Moody AFB, GA · Mountain Home AFB, ID · Nellis AFB, NV · Offutt AFB, NE · Peterson AFB, CO · Robins AFB, GA · Schriever AFB, CO · Scott AFB, IL · Shaw AFB, SC · Sheppard AFB, TX · Tinker AFB, OK · Travis AFB, CA · Vandenberg AFB, CA · Warren AFB, WY · Whiteman AFB, MO · Wright-Patterson AFB, OH
Assess technical, acquisition, schedule, contracting, software development, digital engineering, computing infrastructure, autonomy, cybersecurity, and resource activities across multiple…
Added 53 mins ago
CO
Construction Inspector( I, II, or III)
City Of League City
League City, TX
- $25.38 to $42.93 USD / hour
Working knowledge of word processing, spreadsheet, and database computer software; ability to operate computer and other standard office equipment.
Added 1 hour ago
Quality Analyst
Northrop Grumman
Linthicum Heights
…environments, Northrop Grumman brings informed insights and software-secure technology to enable strategic planning. We are looking for innovators who can help us keep building on our wide…
Added 1 hour ago
Sr Principal Network Administrator - TS/SCI
Northrop Grumman
Dulles
Deliver third-level technical support for complex network, hardware, software, and telecommunications issues
Added 1 hour ago
Engineer II -Store Dev, Sustainability and Coffee Tech
Starbucks Coffee Company
Seattle
As an engineer II, you will be part of the engineering team supporting Coffeehouse Design & Development and Global Coffee & Sustainability. You will develop and maintain applications that…
Added 1 hour ago
R
Engineering Manager, Security (Cloud, Infrastructure & Application Security)
Replit
Foster City, CA
- $250,000 to $387,000 USD / year
Replit is the agentic software creation platform that enables anyone to build applications using natural language. With millions of users worldwide, Replit is democratizing software…
Added 1 hour ago
Sr Software Test Automation Engineer
Intuitive
Sunnyvale, CA
…automation framework for formal verification and validation of Ion software. The role will also include hands on verification/validation, root cause analysis, troubleshooting, and formal…
Added 1 hour ago
Staff Software Engineer
Intuitive
Sunnyvale, CA
BS in Engineering or related technical fields required, MS or PhD preferred.
Added 1 hour ago
Engineer II, Google Cloud
PricewaterhouseCoopers Advisory Services LLC
Chicago, IL · Raleigh, NC · Charlotte, NC · Cincinnati, OH · Cleveland, OH · Columbia, SC · Columbus, OH · Dallas, TX · Baltimore, MD · Richmond, VA · Rochester, NY · Rosemont, IL · Boston, MA · St. Louis, MO · Salt Lake City, UT · San Antonio, TX · Seattle, WA · Spartanburg, SC · Albany, NY · Stamford, CT · Tampa, FL · Atlanta, GA · Toledo, OH · Austin, TX · Tulsa, OK · Washington, DC · Denver, CO · Des Moines, IA · Detroit, MI · Boca Raton, FL · Buffalo, NY · Florham Park, NJ · Fort Worth, TX · Greensboro, NC · Hartford, CT · Houston, TX · Grand Rapids, MI · Jacksonville, FL · Kansas City, MO · Las Vegas, NV · Little Rock, AR · Louisville, KY · Birmingham, AL · Fayetteville, AR · Melville, NY · Miami, FL · Milwaukee, WI · Minneapolis, MN · Montpelier, VT · Nashville, TN · New Orleans, LA · NY · Oklahoma City, OK · Orlando, FL · Philadelphia, PA · Phoenix, AZ · Pittsburgh, PA · Portland, OR
…applications on Google Cloud, supporting work across the full software development lifecycle from new product ideas to modernization efforts. As an Associate you will learn through hands-on…
Added 1 hour ago
MM
Software Engineer I/II
Multi Media LLC
Remote, United States
- $130,000 to $165,000 USD / year
We are looking for a frontend-leaning Software Engineer I/II to join our Viewer team and help build user-facing features that reach millions of people worldwide.
Added 1 hour ago
Engineer II, Software Assurance, Product Security (Remote)
CrowdStrike
Santa Fe, NM
Experience working in an engineering role implementing, supporting, and monitoring software security systems.
Added 1 hour ago
Urology R&D Software Engineering Co-op
Boston Scientific
Maple Grove
As an URO R&D Software Engineering Co-op at Boston Scientific, you will gain hands-on experience designing, developing and testing innovative software solutions that support next-generation…
Added 2 hours ago
Quality Assurance Inspector II (2nd Shift)
TAD PGS, Inc.
Los Alamitos, CA
Performs the in-process and final inspection of products used in airframe and missile manufacturing. Analyze engineering blueprints, process specifications, shop travelers and manufacturing…
Added 2 hours ago
Senior Test Manager-Tinker AFB
Serco USA
Andrews AFB, MD · Aurora Buckley AFB, CO · Cannon AFB, NM · Columbus AFB, MS · Dyess AFB, TX · Edwards AFB, CA · Eglin AFB, FL · Eielson AFB, AK · Ellsworth AFB, SD · Fairchild AFB, WA · Glendale Luke AFB, AZ · Goodfellow AFB, TX · Grand Forks AFB, ND · Hanscom AFB, MA · Hill AFB, UT · Kirtland AFB, NM · Langley AFB, VA · Laughlin AFB, TX · Little Rock AFB, AR · Maslmstrom AFB, MT · Maxwell AFB-Gunter Annex, AL · McConnell AFB, KS · Minot AFB, ND · Moody AFB, GA · Mountain Home AFB, ID · Nellis AFB, NV · Offutt AFB, NE · Peterson AFB, CO · Robins AFB, GA · Schriever AFB, CO · Scott AFB, IL · Shaw AFB, SC · Sheppard AFB, TX · Tinker AFB, OK · Travis AFB, CA · Vandenberg AFB, CA · Warren AFB, WY · Whiteman AFB, MO · Wright-Patterson AFB, OH
Advise government test, engineering, and program leadership on test planning and execution supporting acquisition and sustainment programs.

Pioneer Data Systems

QC Instrument Validation

Rocky Mount, NC, United States

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Job details

Posting language: English
Posted: Sep 29, 2017

Original job description

Job Description

Position Details:

Job Title: Quality/Validation Engineer III / Laboratory Instrument Validation Duration: 09 months contract, extendable up to 18 months Location: Rocky Mount, NC

Note:

Client has the right-to-hire you as a permanent employee at any time during or after the end of contract. You may participate in the company group medical insurance plan which includes dental and vision.

Job Description:

The Quality Engineer III - Instrument Validation will be responsible for:

Serving as validation representative for instruments Partnering with the laboratories, quality system administrators, BT, instrumentation and quality on implementing new instruments at the site Performing analytical instrument validation including computerized system validation if applicable Performing any validation change control during the life-cycle of the system Performing system periodic review Performing system decommissioning This position will be responsible for providing end-user support for all Quality Laboratory groups as well as compliance to global and site internal policies and procedures.

ROLE RESPONSIBILITIES

Initiates and leads change control for implementation of new instruments or changes to existing analytical instrumentation and associated instrument control software where applicable in Quality Control laboratories. Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), reports, addendums and other validation deliverables as required by the site validation SOPs. Assist the system owner with evaluating recommending the appropriate user roles and privileges for data integrity (where applicable), writing instrument operation instructions and preventive maintenance plans. Ensures lab instrument's adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA guidelines. Authors protocol to challenge the main aspects of these requirements during validation to demonstrate adherence. For systems found unable to fully comply, formulate workarounds/strategies with core stake holders to mitigate the gaps. Initiates and leads risk assessment, gap analysis, and deviation management associated with validation of lab instruments. Completes periodic reviews of instruments and instrument control software with focus on change control, deviation investigations, and CAPA to ensure compliance and validated state of the instrument. Previous experience with PR/CAPA systems preferred. Reviews validation deliverables created by others for adherence to site validation SOPs and acts as validation approver as needed. All other duties as assigned.

QUALIFICATIONS

Bachelor's degree in a science or engineering related discipline with knowledge in quality operations laboratory processes. 5-7 years of experience in the validation of laboratory instruments including those with computerized systems attached in a cGMP environment (required). 5-7 years of experience in the Pharmaceutical industry or relevant business experience within Quality Assurance or Validation cGMP Compliance. Hands on experience operating instrument systems. Demonstrated attention to detail. Good oral and legible written communication skills. Must be able to work independently. Mastery of core computer software/systems (Word, Excel, Sharepoint, etc.). Demonstrated ability to work in a team environment and manage workload to meet deadlines. Ability to follow a variety of instructions furnished in written, oral, diagram, or schedule form.

PHYSICAL/MENTAL REQUIREMENTS (not all roles will have physical or mental requirements) Use a computer terminal for up to 8 hours per shift, occasionally lift a maximum of 5 pounds per activity 4 times per shift, work around moving equipment, work with biological materials. Occasionally lift a computer system and/or instrument up to 50 pounds. Stand for up to 8 hours, sit for up to 8 hours, walking, climbing stairs, responding to visual warning indicators, respond to audible warning indicators, respond to color or special visual indicators, wear specialized protective. Mathematical and scientific reasoning ability.

NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS

May be required to work non-standard hours including weekends and holidays to support laboratory processes at the Rocky Mount site. Some gowning may be required to enter laboratory areas. Work safely in laboratory areas where biological and chemical hazards are present.

ORGANIZATIONAL RELATIONSHIPS

Position interacts with laboratories within the Quality unit and impacts their compliance and continuous improvement. Other functions key to the instrument validation process include Laboratory System Administrators, Calibration and Documentation.

Position Comments visible to MSP and Supplier:

Other Considerations:

The official job description of the candidate is Quality Engineer III - Laboratory Instrument Validation.
If the candidate has less than the required 5-7 years of experience in the validation of laboratory instruments, will consider the candidate for Quality Engineer II
Please post this position in an area geared for the laboratory.
In Appendix B, CANDIDATE SCREENING – RESUME COVERSHEET, it would be helpful if the vendors would include the information for at least the 4 skills identified below in addition to anything else they want to add/highlight. Additional Information Anuj Mehta 732-947-3452

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More about this job

Skills

Regulatory compliance
Quality control
Preventive maintenance
Hazard assessment
Pharmaceutical industry
Quality assurance
Attention to detail
Communication skills
Work independently
Microsoft Word
Microsoft Excel
Microsoft SharePoint
Work as a team
Meet deadlines
Use a computer
Process improvement
Documentation

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