Validation Engineer
Company: Comrise
Location: Leesburg
Posted on: August 2, 2022
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Job Description:
OverviewImplementing the company validation strategy, based on
Corporate procedures and regulatory requirements. Supporting
validation activities by providing guidance and expertise to
authors of validation documentation and executors of validation
protocols at the local site. Reviewing and approving of validation
documentation to ensure compliance with regulations and validation
best practices. Will work within the QA Shared Services Validation
Team, responsible for validation related activities, including, but
not limited to the following:
Responsibilities--- Having knowledge of and ability to provide
Interpretation and Guidance on Regulations, Corporate, Divisional
and Site Local procedures as they relate to validation
activities.--- Participating within Corporate Validation Team to
develop and revise Validation Procedures and Templates to ensure
that Current Regulatory Compliance and Company Objectives are
maintained.--- Participating on both Corporate and Local Validation
Teams to discuss / give feedback and approve revisions to
Validation Procedures.--- Representing validation at both internal
and external audits.--- Ensuring that Validation Practitioners
receive training/coaching to allow them to effectively support
and/or perform validations for current and anticipated projects.---
Ensuring that appropriate Systems are in place to evaluate changes
to Validated/Qualified Systems to ensure their continued
validated/qualified state.--- Ensuring that appropriate Site
Validation Listing is established and controlled as per Current
Regulatory and Company Requirements.--- Reviewing and approving of
Validation/Qualification Documentation.--- Working with Validation
Consultants/Contractors as required ensuring that Validations are
completed as per corporate and divisional procedures.--- Being the
site responsible for at least 1 validation specialty and be the
primary support for that specialty and site.--- North America
Qualifications--- Bachelor of Science, Engineering or related
subject with 3 to 5 years of experience in validation, or---
Masters of Science, Engineering or related subject with 1 years or
more of experience in validation--- Excellent communication skills
and attention to detail.--- Have a good understanding of
engineering and machine tool fundamentals.--- High level of PC
skills.--- Must be proficient with Microsoft Word, Microsoft Excel
and PowerPoint packages.--- Self-starter with demonstrated
efficient work methods, analytical & problem solving skills and
ability to handle multiple tasks in a fast paced environment.---
Must be willing to work as part of a multi-site team, be able to
travel as part of the job--- Knowledge of Computer System
Validation including GAMP 5 and 21 CFR part 11 requirements
desirable.--- Working knowledge/experience of Risk Based Techniques
i.e. FMEAs, FTAs etc.--- Have a good understanding of statistical
techniques, in particular statistical sampling plans, Process
Capability, Gauge R&Rs.--- Strong knowledge of Quality Concepts
(e.g. CAPA, Audits, Statistics).--- Highly developed problem
solving and strong analytical skills.--- Lean Six Sigma training a
distinct advantage.
Keywords: Comrise, Leesburg , Validation Engineer, Engineering , Leesburg, Virginia
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