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From a recruiter, please contact him directly if interested.
Hello Professionals,
This is Krishna from KRG TECHNOLOGIES; We are looking for Product Software
Validation Engineer in Ann Arbor, MI
I also kindly request you to forward this opportunity to your friends or
colleagues; so that we can help someone who may be in search of a job or
looking for a change.
Title : Product Software Validation Engineer
Location : Ann Arbor, MI
Duration : 6+ Months Contract
Job description:
Responsibilities:
· Responsible for managing and executing the validation of non-
product software applications (including, but not limited to ERP System, PDM
system, CAPA Management system, Reports, Spreadsheets, MES system),
Equipment and Automated systems (E&AS) and qualification of infrastructure (
i.e. hardware, infrastructure software and infrastructure components) to
assure quality and stability prior to deployment in production environments.
· Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR
Part 11), guidelines and internal procedures related to validation of
computer systems, E&AS and associated infrastructure are followed and
applied during all stages of the defined software development life cycle (
SDLC) and project phase activities.
· Creates validation and qualification deliverables, such as change
impact assessment, user and functional requirement specifications, data
migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc.
for new software, enhancements, maintenance releases, and periodic reviews.
· Analyzes the validation impact of changes and helps in
formulating the validation plan for changes to existing or new computer
systems, E&AS and infrastructure.
· Identifies and coordinates activities and tasks required to
complete qualification and validation activities including reviews with
Quality, obtaining signature approvals, executing qualification protocol or
validation project plan, managing change control (change requests).
· Supports risk assessment and system lifecycle processes such as
change control and document management.
· Assists in resolving and documenting deviations in technical and
project-related issues.
Qualification:
· Education: BS degree in Computer Science, Engineering or other
related discipline.
Required Skills/ Experience:
· Validation experience in a FDA regulated industry.
· Expertise in interpretation of the applicable regulations that
impact computer systems (e.g., 21 CFR Parts 11, 820) used in GxP environment
and related FDA guidelines, regulations.
· Develop validation deliverables including, but not limited to
Validation Plan, URS, FRS, IQ, OQ, PQ, Qualification Reports, Summary
Reports.
· Proficient in validation process methodologies, risk management,
etc.
· Executing IQ, OQ, PQ and other related qualification protocols.
· Expertise in handling Change Control activities
· Good understanding of the SDLC methodologies.
· Must be able to manage multiple projects and be able to work
independently.
· Effective oral and written communication skills.
Skill Matrix:
Required skills
No. of years of experience
Last used year
Validation experience in a FDA regulated industry
IQ, OQ, PQ Protocol
Regulations (21 CFR Part 820 & 21 CFR Part 11)
Risk management
Mechanical Engineering background
Change Control activities
Thanks & Regards
KRISHNA
KRG Technologies Inc
Phone: 214 550 8950 | Fax: 661 257 9968
25000 Avenue Stanford | Suite 243 | Valencia CA 91355
Email:k*****[email protected] | URL:www.krgtech.com Yahoo Messenger: Ranjith_krg
Hello Professionals,
This is Krishna from KRG TECHNOLOGIES; We are looking for Product Software
Validation Engineer in Ann Arbor, MI
I also kindly request you to forward this opportunity to your friends or
colleagues; so that we can help someone who may be in search of a job or
looking for a change.
Title : Product Software Validation Engineer
Location : Ann Arbor, MI
Duration : 6+ Months Contract
Job description:
Responsibilities:
· Responsible for managing and executing the validation of non-
product software applications (including, but not limited to ERP System, PDM
system, CAPA Management system, Reports, Spreadsheets, MES system),
Equipment and Automated systems (E&AS) and qualification of infrastructure (
i.e. hardware, infrastructure software and infrastructure components) to
assure quality and stability prior to deployment in production environments.
· Ensures that the applicable regulations (21 CFR Part 820 & 21 CFR
Part 11), guidelines and internal procedures related to validation of
computer systems, E&AS and associated infrastructure are followed and
applied during all stages of the defined software development life cycle (
SDLC) and project phase activities.
· Creates validation and qualification deliverables, such as change
impact assessment, user and functional requirement specifications, data
migration plan, IQ, OQ, PQ protocol and scripts, qualification reports, etc.
for new software, enhancements, maintenance releases, and periodic reviews.
· Analyzes the validation impact of changes and helps in
formulating the validation plan for changes to existing or new computer
systems, E&AS and infrastructure.
· Identifies and coordinates activities and tasks required to
complete qualification and validation activities including reviews with
Quality, obtaining signature approvals, executing qualification protocol or
validation project plan, managing change control (change requests).
· Supports risk assessment and system lifecycle processes such as
change control and document management.
· Assists in resolving and documenting deviations in technical and
project-related issues.
Qualification:
· Education: BS degree in Computer Science, Engineering or other
related discipline.
Required Skills/ Experience:
· Validation experience in a FDA regulated industry.
· Expertise in interpretation of the applicable regulations that
impact computer systems (e.g., 21 CFR Parts 11, 820) used in GxP environment
and related FDA guidelines, regulations.
· Develop validation deliverables including, but not limited to
Validation Plan, URS, FRS, IQ, OQ, PQ, Qualification Reports, Summary
Reports.
· Proficient in validation process methodologies, risk management,
etc.
· Executing IQ, OQ, PQ and other related qualification protocols.
· Expertise in handling Change Control activities
· Good understanding of the SDLC methodologies.
· Must be able to manage multiple projects and be able to work
independently.
· Effective oral and written communication skills.
Skill Matrix:
Required skills
No. of years of experience
Last used year
Validation experience in a FDA regulated industry
IQ, OQ, PQ Protocol
Regulations (21 CFR Part 820 & 21 CFR Part 11)
Risk management
Mechanical Engineering background
Change Control activities
Thanks & Regards
KRISHNA
KRG Technologies Inc
Phone: 214 550 8950 | Fax: 661 257 9968
25000 Avenue Stanford | Suite 243 | Valencia CA 91355
Email:k*****[email protected] | URL:www.krgtech.com Yahoo Messenger: Ranjith_krg