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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