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Thousand Oaks

    Process Engineer - Thousand Oaks, United States - ACL Digital

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Title: Engineer

    Location: Thousand Oaks, CA

    Duration: 12 + months contract

    This engineering position supports manufacturing activities associated with cGMP equipment and facilities at Amgen Thousand Oaks (ATO). The engineer works in partnership with the automation, maintenance, project management, corporate engineering, and manufacturing to develop and oversee the operation and reliability of equipment while driving safety and quality compliance. The engineer will support the department and capital projects and provide data to support business cases and long term strategy.

    The Engineer role will provide direct engineering technical support as follows:

    Model leadership behaviors and positive values to create a positive working environment.

    Be individually accountable for the consistent equipment performance

    Be accountable for assigned deliverables on key capital projects

    Suggest design modifications to address risks and design in quality and safety.

    Provide oversight for verification deliverables developed by outsourced/contract verification staff.

    Act as a liaison between Engineering and Quality Assurance during project planning, execution, and closeout

    Ensure that validation protocols are executed and documented in accordance with cGMP good documentation and safety compliant practices.

    Ensure safety during commissioning, validation, maintenance, and manufacturing activities

    Related Activities:

    Participate or lead, when required, multidisciplinary site teams, e.g. Cross Functional Team, Root Cause Analysis lead.

    Support Lean Transformation and Excellence in Operations process improvement by leading, supporting, and documenting improvement opportunities to reduce cost, improve safety/quality, or improve speed.

    Provide ad hoc technical support and guidance for manufacturing and maintenance

    Provide coaching and guidance to project teams and engineers using risk-based approaches

    Defend the equipment-specific calibration, maintenance, & validation as required during regulatory inspections

    Participate in internal audits and assess in conjunction with quality assurance

    Assist in developing and maintaining business metric performance

    Preferred Qualifications / Skills / Experience

    Bachelor's degree in engineering or another science-related field

    7+ years of relevant work experience with 5+ years experience in operations/manufacturing environment

    Direct experience with regulated environments (FDA, OSHA, EPA, etc.)

    Working knowledge and experience with cGMP procedures and engineering practices on pharmaceutical/biotech production processes, clean utilities, facilities, instruments, and equipment

    Experience implementing risk-based verification on major GMP process equipment / automation projects, including validation protocol development and execution

    Experience with combination product / medical device quality systems verification

    Process equipment knowledge basic principles of cell culture, fermentation, purification, filling

    Process automation knowledge fundamental understanding of automation infrastructure

    o Knowledge of Delta V, Rockwell, and Plant Information Systems is a plus

    Strong communication and technical writing skills

    Strengths in facilitation and collaboration / networking

    Experience in developing SOPs and delivering training

    Individual must be a team player prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making

    Basic understanding of process improvement methodologies to mature and improve business performance (examples: PDCA, LEAN, Six Sigma, etc.)


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