-
CSV Engineer
3 weeks ago
Trinity Consultants - Advent Engineering Life Science Solutions Rhode Island, United StatesCSV Engineer · Boston/Rhode Island · 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 p ...
-
CSV Validation Engineer
3 weeks ago
Hire IT People Providence, United StatesResponsibilities: · 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 complian ...
-
CSV Engineer
3 weeks ago
DPS Group Global Norwood, United StatesSummary · DPS Group is seeking an enthusiastic and experienced computer system validation engineer to join our team. The Computer System Validation Engineer will be responsible for the Computer System Validation of IT solutions being implemented for a continuous manufacturing fa ...
-
CSV Engineer
2 weeks ago
DPS Group Global Norwood, United StatesSummary · DPS Group is seeking an enthusiastic and experienced computer system validation engineer to join our team. The Computer System Validation Engineer will be responsible for the Computer System Validation of IT solutions being implemented for a continuous manufacturing fac ...
-
CSV Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Bridgewater, United StatesResponsibilities: 7+ years of experience in Computer System Validation · Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedures ...
-
CSV Engineer
3 weeks ago
Katalyst Healthcares and Life Sciences Norwood, United StatesResponsibilities:Manage the Computer System Validation aspect of IT projects from software install to business release · Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration. · Responsibility for server instal ...
-
CSV Engineer
1 week ago
Katalyst HealthCares & Life Sciences Bridgewater, United StatesResponsibilities: 7+ years of experience in Computer System Validation · Reviewing and approving validation deliverables of GxP regulated Computerized Systems to ensure full compliance with Health Authority regulatory requirements and adherence to company policies and procedure ...
-
CQV Engineer
3 days ago
Trinity Consultants - Advent Engineering Life Science Solutions Rhode Island, United StatesCQV Engineer · Boston/Rhode Island · Responsibilities: · Draft and implement Quality System documentation designed to establish good validation practices within the organization. · Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal ...
-
Manager, Infrastructure
1 week ago
J&J Family of Companies Providence, United StatesJ&J Family of Companies · Manager, Infrastructure (1 of 2) · Providence , · Rhode Island · Apply Now · Manager, Infrastructure (1 of W · Description · Johnson & Johnson is recruiting for a Manager, Infrastructure in Raritan, NJ or near a Johnson & Johnson office in India, Sw ...
-
Senior Software Engineer/Developer
1 week ago
Fidelity TalentSource LLC Smithfield, United States· Job Description: · Position Description: · Develops Cloud-based databases and applications using Amazon Web Services (AWS). Performs database administration and development using Oracle. Builds and deploys applications in a DevOps environment using Continuous Integration/Conti ...
-
MES Engineer
3 weeks ago
Insight Global Norwood, United StatesLocation: REMOTE EST hours · Position: MES Engineer - Recipe Author · Pay Range: $80-110/hr · Start date: June 1, 2024 · Must Haves · 5+ years of relevant job experience working in life science or regulatory environment · MES Experience, specifically with Recipe Design experie ...
-
Cleaning Validation Engineer
2 weeks ago
Mastech Digital Norwood, United StatesCSV ENGINEER (All Visas) · DURATION months · Location: Norwood, MA · Responsibilities will include: · We have a CSV project that is high level that they may be a good fit for. They might need expertise in Hamilton's please verify that they have it if it's not on the resume it wi ...
-
remote mes engineer
3 weeks ago
Insight Global Norwood, United StatesA large biotechnology company is seeking an MES Automation Engineer to join their digital/IT organization on the Technical Development side. In this role, the engineer will work with Digital Lab and Digital manufacturing systems from an automation perspective. The MES Engineer wi ...
-
remote mes engineer
3 weeks ago
Insight Global Norwood, United StatesJob Description · A large biotechnology company is seeking an MES Automation Engineer to join their digital/IT organization on the Technical Development side. In this role, the engineer will work with Digital Lab and Digital manufacturing systems from an automation perspective. T ...
-
Technology Development Specialist
22 hours ago
Compunnel Inc. Bedford, United StatesYour main mission will be within the Software Development and Delivery group. As an OT Developer, you will reinforce the Development team with the contribution of your competence and expertise in the design, development, deployment, and validation of industrial software and autom ...
-
System Analysis
3 weeks ago
JobsRUs Bedford, United StatesJob Description · Job is seeking to hire a System Analysis & Consulting Expert for our client in Bedford, MA · Pay rate: 77.00 · Job Title: OT Developer · Onsite at least 3 days/week · Your main mission will be within the Software Development and Delivery group. As an OT Develo ...
-
GIS Technician
1 week ago
Westinghouse Electric Company Canton, United StatesGIS Technician - 12 Months · Gastonia, NC · MUST BE LOCAL TO Gastonia, NC · Are you interested in being part of an innovative team that supports Westinghouse's mission to provide clean energy solutions? At WECTEC Staffing Services, a wholly-owned subsidiary of Westinghouse Ele ...
-
Senior Data Enginer
3 weeks ago
FullStory Brockton, United StatesThis role can be performed remotely anywhere within the United States. · Help unlock the secrets hidden in the vast trove of data at Fullstory. We're looking for an experienced Data Engineer to go spelunking through numerous systems and bring order to a chaotic world. Work with ...
-
Automation Engineer
3 weeks ago
Sirius Staffing Bedford, United StatesSirius Staffing is seeking an Automation Engineer for a hybrid role working in Bedford, MA. · This position will require 3 days working onsite and 2 days working remotely. · Your main mission will be within the Software Development and Delivery group. As an OT Developer, you will ...
-
Sr. GxP Automation Engineer
3 weeks ago
Moderna Norwood, United StatesThe Role · As a Senior GxP Automation Engineer at Moderna, you will play a crucial part of our manufacturing operations, supporting the operation of our cutting-edge Drug Product (Fill Finish) GxP manufacturing systems. These systems include, but are not limited to Allen Bradley ...
CSV Engineer - Providence, United States - Trinity Consultants
Description
CSV EngineerBoston/Rhode Island
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
Experience with 21 CFR Part 11 and Data Integrity.
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.
#J-18808-Ljbffr