Company: Global Channel Management,Inc
Posted on: November 19, 2021
Validation Engineer needs 3-5 years of experience in Quality in
a highly regulated manufacturing environment (Diagnostics, Medical
Device, Pharmaceutical, or Consumer.)
Validation Engineer requires:
B.S. Degree in Chemistry, Biochemistry, Biology, Engineering, or a
Knowledge of current and applicable GMP regulations including
ISO13485 and 21 CFR Part 820.
Strong organization and time management skills.
Advanced Microsoft Office (Word, Excel, PowerPoint, etc.) tools
experience for communications, reporting and data analysis is
Validation Engineer duties:
Provide validation support on process, equipment, software, and
facilities changes while ensuring the validation and qualification
activities are consistent with regulations and validation policies
Generate, review, and approve documentation supporting validation
activities (plans, protocols, reports, technical documents,
Execute functions needed to support change control activities and
document management requirements by collaborating with business
partners and peers to define validation and change control activity
Support validation lifecycle by developing and maintaining
validation change notices, including requirements and process
Participate in process mapping/process analysis and in the
preparation of risk assessments to support investigations and
implementation of process and equipment changes. Participate in the
creation and evaluation of statistical sampling plans and rationale
to support product specifications and validation protocols.
Provide recommendations for amendments to sampling plans to ensure
appropriate product control plans are in place.
Keywords: Global Channel Management,Inc, Rochester , Validation Engineer, Engineering , Rochester, New York
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