-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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. ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
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 ...
-
Validation Engineer
1 week ago
Katalyst Healthcares and Life Sciences Jersey City, United StatesResponsibilities: 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 va ...
-
Clean Validation Engineer
1 week ago
Trinity Consultants New York, United StatesADVENT's services include process engineering, automation engineering, project engineering, HVAC/facility system design, process development, start up and commissioning, validation and compliance consulting for distinguished and successful biotechnology and pharmaceutical manufac ...
-
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 ...
-
HiL Validation Engineers
1 week ago
Akkodis New York, United StatesAkkodis is seeking two experienced 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 CAPL scripting for ...
-
Senior Validation Engineer
1 week ago
BioPhase New York, United States*US Citizens or Greencard Holders only* · **No C2C** · Work Schedule: · Onsite - M-F · Salary: · $60-70/hr · Duration: · 4 months · Primary Responsibilities: · Support the Quality Engineering group with documentation and validation needs. · Draft URS documents, design specif ...
CSV Validation Engineer - New York, United States - Hire IT People
Description
Responsibilities:
Draft and implement Quality System documentation designed to establish good validation practices within the organization.
Author URS, FRS, Risk Assessments, Configuration specification, design specification and CSV test protocols and execute them in compliance with GDP guidelines and internal quality standards.
Author and develop SOP and VMP for computer system validation for manufacturing equipment.Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports.
Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
Comply with all regulatory, corporate, and Quality System policies
Qualifications:
B.S. / M.S. in engineering or another relevant discipline.
Minimum of 5+ years of experience working within a medical device environment or other FDA regulated environments. Experience with device-biologic combination products is highly desirable.
Experience in the areas of Design Documentation (URS, FRS, CS, DS, and other engineering specifications) and Validation (OQ, CSV, etc.)
,Understanding of c.
G.x.
P principles and familiarization with ISO 13485, ISO 14971, and 21C.F.R.820
Working knowledge GAMP 4 and GAMP 5 categorization and their respective deliverables for Computer Systems Validation lifecycle.
Proficient in Microsoft Word, Excel, PowerPoint.
Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
Must demonstrate strong communication, interpersonal and teamwork skills.
A strong understanding of technical writing and presentation skills is required.