BostonRecruiter Since 2001
the smart solution for Boston jobs

Sr. CSV Engineer @ Providence, RI

Company: Cerebra Consulting Inc
Location: Boston
Posted on: August 3, 2020

Job Description:

Cerebra Consulting Inc is a System Integrator and IT Services Solution provider with a focus on Big Data, Business Analytics, Cloud Solutions, Amazon Web Services, Salesforce, Oracle EBS, Peoplesoft, Hyperion, Oracle Configurator, Oracle CPQ, Oracle PLM and Custom Application Development. Utilizing solid business experience, industry-specific expertise, and proven methodologies, we consistently deliver measurable results for our customers. Cerebra has partnered with leading enterprise software companies and cloud providers such as Oracle, Salesforce, Amazon and able to leverage these partner relationships to deliver high-quality, end-to-end customer solutions that are targeted to the needs of each customer. Position SR. CSV Engineer Location Providence, RI Duration 6 months Position Description Responsibilities Draft and implement Quality System documentation designed to establish good validation practices within the Organization. Work with system owners on Data Integrity and CSV assessment and provide guidance for CSV policies and procedures. Design validation approaches, draft validation protocols, perform andor coordinate all validation activities, analyze and assemble results, and draft validation reports. Draft and execute IQOQPQ protocols for software, PLC hardware, and IT systems. Provide input on user andor 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. Assist in training and mentoring staff in the technical competencies of computer validation and in contributing to validation projects. Execute assigned duties on time and within budget pro-actively telegraph delays and other issues to relevant stakeholders. Comply with all Regulatory, Corporate, and Quality System policies Complete other projects andor assignments as required. Qualifications B.S. M.S. in Computer Science or another relevant engineering discipline. Minimum of 5+ years of experience working within regulated manufacturing. Direct experience with CSV of GxP systems is mandatory. Demonstrated knowledge of cGMP manufacturing as well as regulatory regulations and requirements for medical devices, biotechnology, and pharmaceuticals with an emphasis on 21 CFR Part 11, including Annex 11, and Data Integrity. Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc) Familiarization with ISO 13485 and 21 CFR 820. 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 verbal, written, presentation, interpersonal and teamwork skills. Required Skills Direct CSV or CxP systems exp Strong validation exp Familiarization with ISO 13485 and 21 CFR 820.SDL2017

Keywords: Cerebra Consulting Inc, Boston , Sr. CSV Engineer @ Providence, RI, Engineering , Boston, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Engineering Jobs


Virtualization Engineer
Description: Virtualization Engineer-2000424DescriptionResponsible for the design, implementation, and support of the VMWare and VDI infrastructure for the bank. Successful candidate will collaborate with architects, (more...)
Company: Santander Holdings USA Inc
Location: Boston
Posted on: 08/9/2020

Senior Manager, Process Engineering
Description: In June 2019, Vertex announced the establishment of new research sites in Boston and Providence where research, development, and clinical manufacturing for cell and genetic therapies will be primarily (more...)
Company: Vertex Pharmaceuticals Inc (US)
Location: Boston
Posted on: 08/9/2020

Cloud DevOps Engineer - Cloud Platform Team - Remote
Description: Job DescriptionCloud DevOps EngineerCompetitive salaryRemote, Anywhere USA br br Dell Technologies has had a 35-year history and track record of delivering ground-breaking products, solutions and (more...)
Company: Dell
Location: Lynn
Posted on: 08/9/2020


Cloud DevOps Engineer - Cloud Platform Team - Remote
Description: Job DescriptionCloud DevOps EngineerCompetitive salaryRemote, Anywhere USA br br Dell Technologies has had a 35-year history and track record of delivering ground-breaking products, solutions and (more...)
Company: Dell
Location: Stoughton
Posted on: 08/9/2020

Principal Engineer, Storefront
Description: Principal EngineerWayfair believes everyone should live in a home they love. Through technology and innovation, Wayfair makes it possible for shoppers to quickly and easily find exactly what they want (more...)
Company: Wayfair
Location: Boston
Posted on: 08/9/2020

Principal Engineer, Storefront
Description: Principal Engineer br br Wayfair believes everyone should live in a home they love. Through technology and innovation, Wayfair makes it possible for shoppers to quickly and easily find exactly what (more...)
Company: Wayfair
Location: Boston
Posted on: 08/9/2020

Cloud DevOps Engineer - Cloud Platform Team - Remote
Description: Job DescriptionCloud DevOps EngineerCompetitive salaryRemote, Anywhere USA br br Dell Technologies has had a 35-year history and track record of delivering ground-breaking products, solutions and (more...)
Company: Dell
Location: Lincoln
Posted on: 08/9/2020

Oil Burner Technician
Description: Oil Burner Technician in Somerville, MA About Us Our 70-year-old company has doubled in size in just the past 6 years, and has hundreds of 5 star reviews on line. Cubby hires for full-time, part-time (more...)
Company: Cubby Oil
Location: Somerville
Posted on: 08/9/2020

Cloud Security DevOps Engineer
Description: What you'll be doing At Verizon, we're expanding our Cloud Security organization and are seeking candidates with readiness to learn and build their security skills in exciting and growing field of DevOps, (more...)
Company: Verizon
Location: Boston
Posted on: 08/9/2020

Cloud DevOps Engineer - Cloud Platform Team - Remote
Description: Job DescriptionCloud DevOps EngineerCompetitive salaryRemote, Anywhere USA br br Dell Technologies has had a 35-year history and track record of delivering ground-breaking products, solutions and (more...)
Company: Dell
Location: Maynard
Posted on: 08/9/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Boston RSS job feeds