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inSync Staffing

inSync Staffing is hiring: Manufacturing Specialist in Hillsboro

inSync Staffing, Hillsboro, OR, United States, 97104

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This range is provided by inSync Staffing. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$36.00/hr - $47.00/hr

Job Responsibilities:

  • Develop and implement novel approaches to solving complex operational problems while maintaining safety, quality, and production standards.
  • Drive process improvement initiatives to enhance efficiency, reduce waste, and ensure compliance with regulatory requirements.
  • Lead root cause analysis (RCA) and structured problem-solving sessions to identify and address unplanned events, reducing recurring issues.
  • Optimize manufacturing processes through Lean principles, Overall Equipment Effectiveness (OEE), and Six Sigma methodologies.
  • Support and enhance tech transfers and process resolutions to improve Fill Finish manufacturing operations.

Compliance & Regulatory Support

  • Own and actively manage deviations, change records, and compliance actions related to operational activities, procedures, and processes.
  • Perform technical and operational reviews of documentation related to process design, validation, operation, and maintenance.
  • Serve as a Subject Matter Expert (SME) and provide technical support during regulatory inspections.
  • Ensure compliance with current Good Manufacturing Practices (cGMPs), sterility assurance, and industry best practices in aseptic processing.

Data Analytics & Business Insights

  • Interpret customer and business needs to develop data-driven solutions and process models.
  • Build analytical tools using structured and unstructured datasets to automate data analytics and track key performance indicators.
  • Present data-driven insights to stakeholders, driving informed decision-making and business improvements.

Manufacturing Readiness & Equipment Optimization

  • Manage product transfers and new equipment/process start-up, including manufacturing readiness, process design, document development, engineering runs, and equipment setup.
  • Provide technical guidance on aseptic manufacturing equipment, including isolators, filling machines, inspection & packaging systems, and sterilization technologies.
  • Review and resolve operational and process discrepancies to enhance manufacturing efficiency and product quality.
  • Lead coordination and issue resolution across HTO Manufacturing Operations, support teams, and cross-functional projects.
  • Actively participate in customer support meetings and strategic discussions related to process improvements.
  • Coach and mentor technicians, leaders, and peers on topics such as Lean, OEE, RCA, and project/program management.

Who You Are

Minimum Qualifications:

  • Bachelor’s degree in Life Sciences, Physical Sciences, Engineering, or an equivalent combination of education and experience.
  • 5+ years of experience in the pharmaceutical industry with progressive responsibility.
  • Strong problem-solving skills with a track record of troubleshooting and resolving process-related issues while ensuring regulatory compliance.
  • Experience working with large datasets (structured and unstructured), deriving actionable insights, and presenting findings to stakeholders.
  • Deep understanding of quality systems, cGMPs, and aseptic processing regulations.
  • Working knowledge of aseptic manufacturing principles, including sterility assurance, microbiology, and regulatory guidelines.
  • Experience with manufacturing process equipment such as isolators, filling, inspection, and packaging machines.
  • Ability to work independently within broad guidelines, requiring guidance only in complex situations.
  • Strong stakeholder management and influencing skills, even in scenarios without direct managerial authority.

Preferred Qualifications:

  • Experience in continuous improvement initiatives related to process, equipment, and quality systems.
  • Knowledge of Lean Manufacturing, Six Sigma, and other operational excellence methodologies.

Benefits:

  • Health insurance
  • Health savings account
  • Vision insurance
  • Flexible spending accounts
  • Life insurance

All qualified applicants will receive consideration for employment without regard to age, race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Seniority level

Mid-Senior level

Employment type

Contract

Job function

Industries

Staffing and Recruiting

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