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Principal Packaging Engineer

Company: BaronHR Technical
Location: Orange
Posted on: January 17, 2020

Job Description:

BaronHR Technical is recruiting for a Principal Packaging Engineer to work for a medical device company in Irvine, CA in a W2 6 month contract role: with possible extension. - Provide packaging, quality compliance, and regulatory expertise for THV Packaging against EU MDR requirements in support of necessary regulatory submissions and on-going validation/verification programs. Provide support for THV Packaging MDD/MDR program including but not be limited to: Research and document packaging gap assessments for sterile and non-sterile packaging configurations. Review existing Design Verification documentation and associated attachments. Review existing Stability (Aging) documentation and associated attachments. Review existing Installation Qualification (IQ), Operational Qualification (OQ), and Performance/Process Performance Qualification (PQ/PPQ) documentation and associated attachments. Revise/create packaging related documentation including but not limited to protocols, reports, technical summaries, and other documents as needed to support ongoing regulatory efforts. Provide support for Cleaning and Sterilization validations and qualifications, including but not limited to protocol and report creation and review, gap assessments, and on-going validation follow-up. Creation and review of Risk Management documentation including but not limited to FMEAs, Risk Management Plans (RMPs), and Risk Management Reports (RMRs). Other technical support related to ongoing Regulatory MDD/MDR projects. Training on document control system and/or any other training required to complete the activities required Deliverables, may include but not limited to: Including but not limited to written Gap Analyses, Compliance Assessments, Protocols, Reports, and other documentation required to support the activities as described in section 2.1. Education/Experience: Bachelor's Degree in Engineering or Scientific field with minimum of 8 years including either industry or industry education Required or Master's Degree or equivalent in Engineering or Scientific field with minimum of 7 years including either industry or industry/education Required or PhD. or equivalent in Engineering or Scientific field with minimum of 6 years including either industry or industry/education - Required Skills: Clinical trials, documentation, engineer, operations, package design, Medical device packaging. Additional Skills: Packaging, packaging engineer, packaging systems, process development, process validation -

Keywords: BaronHR Technical, Orange , Principal Packaging Engineer, Engineering , Orange, California

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