- Primarily responsible for the support and execution of laboratory equipment qualification and associated computer system validation activities in compliance with current cGMP regulations and client's corporate principles, quality policies, standards, and core values.
- You will work closely with instrument vendors, facilities, IT, and lab personnel to coordinate the installation and the qualification including computer system validation, of QC Equipment.
- Perform qualification of laboratory equipment following EQ policies, plans, and procedures.
- Coordinate with laboratory personnel to define qualification requirements.
- Author, review, and execute equipment qualification protocols.
- Coordinate equipment qualification activities with vendors and other support groups.
- Coordinate equipment maintenance activities with vendors and other support groups, as required.
- Identify business, quality, and compliance gaps and propose and implement potential improvements to systems and procedures
- Sign documents for activities as authorized and described by the client's policies, procedures, and job descriptions.
- Provide input to technical / investigation reports.
- Identify, troubleshoot, and propose a resolution to technical problems.
- Receive and provide training.
- Provide input to and participate in assay transfer/validation associated with equipment qualification/lifecycle.
- Coordinate with customers to support multi-site operational activities.
- Present equipment lifecycle and associated procedures/material during internal and external audits and regulatory inspections.
- Works to meet schedules and set timelines.
- Perform other duties as requested by managers to support Quality activities.
- Bachelor's degree (Life Science, Engineering)
- Three to six years of validation experience (or equivalent experience) in a cGMP environment with increasing levels of responsibility for a wide range of validation projects including validation of large-scale biochemical manufacturing, utility, and automation systems.
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Cummins New York, United States**Product Validation Engineering Technician · - 1st Shift** · **Pay Range $30.46- $45.69** · Our culture believes in _POWERING YOUR POTENTIAL_. We provide global opportunities to develop your career, make your community a better place and work with today's most innovative thinker ...
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Validation Engineer
1 week ago
Katalyst HealthCares & Life Sciences Jersey City, United StatesResponsibilities · : · Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. · You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA a ...
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Validation Engineer
1 week ago
Cynet Systems Jersey City, United StatesJob Description: · Pay Range $50hr - $55hr Support cross functional teams in processing documents (assist in document editing, review, approvals). · ssist in process improvements for Document Control Management/Training processes. · Revise SOPs related to Document Control/Train ...
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Validation Engineer
1 week ago
Katalyst HealthCares & Life Sciences Jersey City, United StatesResponsibilities : Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. · You should have excellent understanding of CFR Part , ICH standards, EMA and FDA (G ...
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Validation Engineer
1 week ago
Glatt Group New York, United StatesJob description · Essential Job Function: · 1. Must have the ability to develop validation protocols (IQ and OQ), validation reports, and factory acceptance test documents. As such, good writing and grammar skills and attention to detail are essential. · 2. Experience is required ...
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Validation Engineer
1 week ago
HCLTech New York, United StatesJob Description : · 1) 7 to 9 years of Experience in Software verification and testing activities. · 2) Design, develop, and execute comprehensive test plans, test protocols and test cases for verification and validation of embedded software. · 3) Collaborate with cross-function ...
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Validation Engineer
6 days ago
Premier Life Sciences LLC New York, United StatesNot For C2C Candidates Please do not apply even not enquire · Job Title: CQV Validation Engineer · Location: Countrywide USA · Contract Duration: 12+ months · Pay: Negotiable on w2 without any benefits · Responsibilities: · Authoring, editing, and executing technical commission ...
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Validation Engineer
1 week ago
eTeam New York, United StatesJob Title: Validation Engineer · Location: Athens, GA · Duration: 06 months · Duties: · Perform Smoke studies and assist in semi-annual Media fill qualifications as a SME Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold rooms, freezers and ware ...
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Validation Engineer
6 days ago
Aequor Inc New York, United StatesPosition: Validation Engineer · Location: Summit NJ 07901 · Duration: 6+ months (possibility of extension for the right candidate depending on performance) · Pay rate: $78.66/ hour on W2 · 100% onsite · Highly preferred cell therapy equipment commissioning qualification. · Mus ...
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Validation Engineer
1 week ago
Aequor Inc New York, United StatesValidation Engineer I/ II · Location: Athens, GA · Duration: 6+ Months with possible extension. · Duties: · Perform Smoke studies and assist in semi-annual Media fill qualifications as a SME. · Perform requalification/periodic review of autoclaves, depyrogenation tunnels, cold ...
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Validation Engineer
1 week ago
Aequor Inc New York, United StatesJob Title: Validation Engineer · Location: Athens, GA · Duration: 1 Year contract + Will be extend · Shift hours: 40 Hours in a week · Pay Range: $40-48/hr. on W2. · Job Description: · Duties: · Perform smoke studies and assist in semi annual Media fill qualifications as a SME. ...
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Validation Engineer
1 week ago
Ascendum KPS New York, United StatesJob description · Improving manufacturing processes using engineering methods (e.g., LEAN methods, basic statistics) for continuous process improvement. · Developing basic experiments and tests (including writing and executing protocols) to qualify and validate manufacturing proc ...
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Validation Engineer
6 days ago
Pyramid Consulting New York, United StatesImmediate need for a talented · Validation Engineer - I (Assistant) . This is a · 06+ Months Contract · opportunity with long-term potential and is located in · West Point, PA(Onsite) . Please review the job description below and contact me ASAP if you are interested. · Job ...
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Validation Engineer
2 days ago
ALTEN Technology USA New York, United StatesWe're ALTEN Technology USA, an engineering company that provides solutions for engineering, technology, and product development projects. For decades, we've been helping our clients develop products that are changing the world, from the efficient heavy truck of tomorrow to a full ...
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Validation Engineer
1 week ago
Katalyst Healthcares and Life Sciences New York, United StatesResponsibilities:Review qualification requirements for any new instrument, equipment and process with system owner and cross-functional teams. · Prepare protocols and reports related to equipment/system/utility qualification (IQ/OQ/PQ), calibrations, engineering, process, packagi ...
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Validation Engineer
2 days ago
Premier Life Sciences LLC New York, United StatesNot For C2C Candidates Please do not apply even not enquire · Job Title: CQV Validation Engineer · Location: Countrywide USA · Contract Duration: 12+ months · Pay: Negotiable on w2 without any benefits · Responsibilities: · Authoring, editing, and executing technical commission ...
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Validation Engineer
1 week ago
Novozen Healthcare LLC New York, United StatesWhat You'll Do · o Commissioning Forms · o C/Q/V Protocols and Summary Reports · o Standard Operating Procedures · o Impact Assessments · o Specifications (URS/FRS/DDS) · o FATS/SATs · Perform field/site activities including, but not limited to, the following: · o Attend and w ...
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Validation Engineer
3 days ago
LS Solutions Inc. New Jersey, United States Full time, contract, trainingKey Responsibilities Strong Experience in Computer Systems Validation (CSV) within the pharmaceutical industry. Required Bachelor's degree in pharmaceutical Science OR related field of study. Schedule and plan equipment and process qualification workload to meet approved schedule ...
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Sr. Validation Engineer
1 week ago
Yoh, A Day & Zimmermann Company New York, United StatesOur client, a global bio-pharmaceutical company, that specializes in core therapeutic and business areas, including gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines, is actively looking to add a · Sr. Validation Engi ...
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HiL Validation Engineers
1 day ago
Akkodis New York, United StatesAkkodis is seeking several junior to senior-level HiL Validation Engineers for full-time roles in the Detroit Metropolitan area. Qualified candidates will possess more than three years of professional experience in hardware-in-loop testing (bench) accompanied by Python and/or CAP ...
Validation Engineer - Jersey City, United States - Katalyst Healthcares and Life Sciences
Description
Responsibilities:
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