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Added 26 mins ago
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M365 Support Engineer
TEKsystems
Boston, MA
- $40 to $55 USD / hour
Target Profile: Eng or Sr Eng M365 / Power Platform Engineer
Added 32 mins ago
Senior Product Development Engineer
Sirtex Medical Inc
Woburn, MA
Sirtex Medical is hiring a Sr. Product Development Engineer to serve as the senior individual-contributor technical authority. You will provide project leadership, own the technical…
Added 1 hour ago
Sr. Systems Engineer - AI Gateway Platform(Remote)
CrowdStrike
Jefferson City, MO
CrowdStrike is seeking an experienced Systems Engineer to own, scale, and secure our enterprise Kong AI Gateway platform as a core technical pillar of the AI Platform Enablement team. This…
Added 1 hour ago
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Sr. Electrical Engineer/Project Manager
GPAC
Columbus, OH
- $95,000 to $155,000 USD / year
Function as lead electrical engineer for multi-discipline projects, through all phases of process
Added 1 hour ago
Sr. Manufacturing & Controls Engineer
Clarios
Saint Joseph, MO
The Engineer will develop and implement process specification changes, create and update Operator and Maintenance Work Instructions, and maintain Assembly Process Flow Charts and PFMEA…
Added 1 hour ago
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Jr & Sr Mechanical Design Engineer
GPAC
St Louis, MO
- $95,000 to $150,000 USD / year
Mechanical Design Engineer – HVAC / Building Systems
Added 1 hour ago
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Jr & Sr Mechanical Design Engineer
GPAC
St Louis, MO
- $95,000 to $150,000 USD / year
Mechanical Design Engineer – HVAC / Building Systems
Added 1 hour ago
Sr. Systems Engineer - EADGE-T
Lockheed Martin
Virtual Three, CO
EADGE-T is seeking a software engineer to join one of the agile development teams. In this role, you will:
Added 2 hours ago
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Sr. Principal Design Quality & Reliability Engineer - OCI Data Center Infrastructure
Oracle
Jefferson City, MO
- $146,300 to $306,400 USD / year
Added 2 hours ago
Process Reliability Engineer
Austin Powder Co., Inc.
McArthur, OH
…colleagues who feel more like family. Job Summary Reliability Engineer The Reliability Engineer works closely with plant management, plant engineers, maintenance, environmental, safety,…
Added 2 hours ago
Principal/Sr Principal Software Engineer Guidance Navigation Control (GNC)
Northrop Grumman
Beavercreek, OH
We are looking for you to join our team as a Principal or Senior Principal Software Engineer - Guidance Navigation Control (GNC) based out of Beavercreek, OH . As a Software Engineer at…
Added 4 hours ago
Media Supervisor
The Shipyard
San Diego, CA
…communications, media and digital landscape. Uniquely designed to Engineer Brand Love through a unifying approach of paid, owned and earned channels, we work together to grow brands that…
Added 4 hours ago
Senior Continuous Improvement Program Manager - Oahu
Hawaiian Electric
Pearl City, HI
Owns and maintains the continuous improvement and operational excellence roadmap for the Power Supply Process Area, ensuring alignment with Generation and Company strategic objectives.…
Added 5 hours ago
Sr. Site Reliability Engineer, Playout
NBC Universal
Miami, FL
NBCU is looking for creative engineers willing to learn from the current process but are not afraid to think outside of the box. This role is responsible for the engineering, operations,…
Added 5 hours ago
Sr Technology Project Manager, Progression
TECO Energy
Tampa, FL
Added 5 hours ago
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Sr Digital Solution Engineer - Cloud & AI Data
Microsoft
United States
- $106,400 to $222,600 USD / year
…we invite you to join our team as a Cloud & AI Data Solution Engineer for education customers at Microsoft…
Added 5 hours ago
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Senior Hardware Engineer
Microsoft
CA · WA · TX · NC · OR · Mountain View, CA · Redmond, WA · Austin, TX · Raleigh, NC · Hillsboro, OR · Mountain View · Redmond · Austin · Raleigh · Hillsboro
- $119,800 to $261,000 USD / year
…AI, and agentic workflows. We are looking for a Sr. Hardware Engineer to solve challenging hardware, firmware, software, and system-level problems across Microsoft’s Global Azure Cloud…
Added 5 hours ago
Sr. Automation Engineer
Phantom Staffing
Greenfield · Greenfield, IN
…including coordinating cross functional teams in support of this…
Added 5 hours ago
GA
Sr Staff Applications Operations Engineer – Engineering Tools Automation & AI Ops
GE Aerospace
Providence, RI
- $131,000 to $174,000 USD / year
Added 5 hours ago
Sr. Principal Quality Engineer
Cardinal Health
Earth City, MO
This role would be accountable for the development and execution of standardized validation protocols for product, process, and cleaning validations within a contract pharmaceutical…
Added 5 hours ago
Principal Microelectronics Semiconductor Manufacturing Engineer/Sr. Principal Microelectronics Semiconductor Manufacturing Engineer
Northrop Grumman
Elkridge, MD
…highest quality. The microelectronics semiconductor manufacturing engineer will support our highly automated SMT manufacturing environment. Manufacturing engineers are the process owners…
Added 6 hours ago
Senior Embedded Systems Verification Engineer
Eaton Corporation
Raleigh, NC
Eaton’s Critical Power Solutions Division (CPS) is seeking an Embedded Systems Verification Sr. Engineer. This position can be based on a hybrid basis in Raleigh, NC. Relocation is…
Added 7 hours ago
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Advanced Mechanical Engineer - Heat Exchangers
Honeywell Technologies
Houston, TX
- $114,000 to $163,000 USD / year
Be part of a team that applies its expertise and knowledge across Honeywell UOP's broad portfolio of process technologies in refining, petrochemicals, gas, and renewables areas. You will…
Added 7 hours ago
HT
Advanced Chemical Engineer- Fired Heaters
Honeywell Technologies
Houston, TX
- $104,000 to $149,000 USD / year
Be part of a team that applies its expertise and knowledge across Honeywell UOP's broad portfolio of process technologies in refining, petrochemicals, gas, and renewables areas. You will…
Added 8 hours ago
SI
Senior Manager, Competitive Intelligence PACE & Agentforce
Salesforce, Inc.
Remote, United States
- $150,100 to $227,000 USD / year
Must have 5+ years of pre-sales, technical or implementation experience (e.g. solutions engineer, enterprise architect, technical architect, implementation specialist, solutions consultant).

Validation & Engineering Group

Sr Quality Assurance (Validation) Engineer - FL, USA

Deerfield Beach, FL, United States

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Job details

Experience: · Minimum 5 years' experience in a Quality Assurance role related to computerized systems compliance.
Posting language: English
Posted: Apr 16, 2021

Original job description

Company Description Validation & Engineering Group (VEG) is a leading services supplier provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

Job Description

Reporting to the Senior Quality Assurance Manager, this position is responsible for Quality oversight of the local validation program which includes Facilities, Utilities, Manufacturing equipment and Computer Systems. The Engineer will contribute improving systems/applications quality by appropriately monitoring processes and providing recommendations for improvement opportunities for any given area of Operations, Process Development, and IT. The engineer will approve validation, change control, investigation of events as well as provide Quality oversight and/or Quality approvals for GxP systems. The CSQA Engineer will provide oversight of SHL Pharma GxP related applications, and established Quality Operating procedures. In addition; will maintain a list of all computerized systems that are used in support of manufacturing operations, assure 21 CFR Part 11 pre- and post-assessments are performed on all systems and that computerized systems are released to production in accordance with local and global policies and procedures. The CSQA Engineer will review and approve validation documentation, including assessments, validation plans and reports, requirements, specifications, protocols and reports, test scripts and discrepancies. In addition, will provide guidance to project teams on the deliverables required as part of the validation package. Assure that computerized systems are in the requalification program and are part of the program for security access roster review. · To Implement and maintain global and local procedures for computerized systems validation. · To drive standardization and continuous improvement activities across the global and local quality network · To provide QA oversight, review and approval of the activities related to the design, test, implementation, and maintenance of supported GxP systems.

· To help plan audit program and execute audits of:

Suppliers of computerized systems, components, and services
Computerized systems, projects and processes related to Computerized system.
Computerized systems at SHL’s partners (e.g. CMO Customers}, upon request · To monitor Quality Metrics and communicate to management to drive continuous improvement of regulated computerized systems and GXP relevant infrastructure. · To Identify and communicate risk in area of responsibility and across the quality network; creating strategies and plans to manage the risk. · To ensure deviations from established procedures are documented per procedures. · To ensure that all changes that potentially impact product quality are documented per procedure. · To ensure all deviations from established procedures are appropriately documented and investigated to determine and fix root cause. Advises site management regarding Quality Assurance issues

Qualifications

· Bachelor’s degree in Computer Science / Computer or Biomedical Engineering · Minimum 5 years' experience in a Quality Assurance role related to computerized systems compliance. · Demonstrated knowledge of predicate rules such as GLP, GMP, GCP, GAMP 5 as they relate to computerized systems. · Must have a strong knowledge and application of the CFR’s and cGMP’s. · Comprehensive knowledge of FDA, EMA, JP, ISO and other regulations and experience in US and international regulatory agency inspections. · Knowledge of regulations and practices pertaining to pharmaceutical/medical devices products in your area of responsibility. · Direct experience reviewing and/or authoring standard operating procedures and partnering with operations on product related investigations and deviations. · Excellent oral and written communication skills with strong technical writing experience required. · Experience in internal / external audits, identify findings, drive resolution and provide closure report. · Proficient skills in solving complex problems and ability to bring issues to resolution. · Proficient skill in handling multiple responsibilities, tasks and projects simultaneously including ability to shift priorities. · Must be able to successfully pass a pre-employment drug test and background check. Experience working globally with diverse teams and cultures

Additional Information All your information will be kept confidential according to EEO guidelines.

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