Validation Engineer
Company: Comrise
Location: Leesburg
Posted on: August 1, 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
AmericaQualifications--- 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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