IT Validation Specialist (Pharmaceutical Industry)
Company: datanet IT
Posted on: May 4, 2021
Job DescriptionOur client, a leading Danish multinational
pharmaceutical company headquartered in Denmark, with production
facilities in eight countries, and affiliates or offices in 5
countries is seeking an IT Validation Specialist who has experience
in the following:Position Purpose:Primary responsibility is to
provide/lead validation services required for the successful
delivery of General, IT & Automation Projects, including New System
Validation, Investigations & Deviations & Capital Projects using a
home grown validation document & execution
- Provide validation & technical support through the validation
lifecycle including: Document generation (Validation Plans,
Specifications, Procedures, Validation Reports, etc.), System
Assessments (System Impact, Data Integrity, Security, etc.),
testing protocols (IQ, OQ, PQ, GEP), and room re-qualification with
comprehensive temperature mapping.
- Ownership of Change Requests (CRs) related to project
- Perform compliance & technical reviews/approvals of test
- Create new & modify existing validation procedures as
- Lead validation failure investigations & support systematic
problem solving to identify root cause.
- Review & approve specifications, procedures & other required
supporting documents to maintain the validated state of equipment &
- Participate in commissioning efforts for equipment, automation
systems & processes & successfully transition into the ownership
role for validation efforts related to the equipment, system or
- Identify process improvements before equipment, systems or
processes are placed under change control during validation.
- Validation budget control/oversight & reporting on remaining PO
- Support PM with contractor scheduling & oversight, as
needed.New Systems Validations:
- Author & Manage Change Requests for Computer System Validation
& room re-qualification.
- Author Validation Documentation: Validation Plans,
Specifications, System Assessments (System Impact, Security,
Quality, Data Integrity), System Definitions, SOPs, User Guides,
Testing Protocols (IQ, OQ, PQ, & GEP) & Reports.
- Execute assigned test protocols & system baselines for
validated systems per approved timeframes.
- Ensure validation documentation/protocols that are
authored/executed are in compliance with local, corporate &
regulatory regulations.Validation Related Investigations &
- Lead the investigations of deviations per approved
- Lead project teams to help identify root causes of failures &
implement corrective actions which address & eliminate potential
re-occurrence of the deviations.Minimum Requirements:
- BA/BS in Engineering, Computer Science, or applicable technical
- Minimum of seven (3) years of computer system validation or
quality related discipline experience in pharmaceutical
- Minimum of one (1) year of project resource experience for
small to medium sized projects with experience developing
validation deliverables. .Technical/Process/Functional Knowledge:
- Knowledgeable in the following areas:
- Understanding of system development lifecycle including
validation of computer systems, operation & maintenance &
decommissioning of systems.
- Understanding of manufacturing processes for manufacturing
areas (aseptic, inspection, assembly, packaging, utilities &
- Expert in GxP documentation practices.
- Proficient in basic computer skills including experience in the
use of Microsoft Office.
- Ability to independently write protocols & technical documents
- Excellent oral & written communication skills.
- Demonstrated knowledge of regulatory audits & inspections.
- Demonstrated knowledge of project teams driving deliverables,
tasks & activities for computer system validation.
- Expert in utilizing appropriate root-cause analysis tools &
techniques.Company DescriptionWith over 35 years of experience
providing the latest in IT solutions, datanet IT is at the
forefront of the technology industry. Our record includes thousands
of successful deployments, which have helped us earn a reputation
for excellence. By offering the best in products, expertise and
customer service, we are able to deliver reliable and
cost-effective solutions that are customized to meet the needs of
individual customers.From small businesses to large enterprise
level corporations, our customers trust us to address their needs
and rely on us for fast and reliable service. Whether they need
help with professional IT services or personnel staffing, dataNet
IT is the go-to source for the businesses who demand only the
best.Our services are specially designed to help our clients reach
new levels of success by implementing cutting-edge solutions,
providing forward-thinking services and supplying highly
experienced personnel. When you partner with dataNet IT, you will
experience: Industry leadership that reflects the latest in
technological advancements Outstanding support that results in
long-term professional relationships Over three decades of
experience working with other top professionals in their fields
Flexible, scalable and fully customized solutions Fast response
times that keep pace with businessContact us today to find out
Keywords: datanet IT, Raleigh , IT Validation Specialist (Pharmaceutical Industry), Healthcare , Clayton, North Carolina
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