Manufacturing Specialist

inSync Staffing; Hillsboro (OR); On-site; USD 72,000 - 96,000; Full time

Benefits offered by this job

Health insurance

Health savings account

Vision insurance

Flexible spending accounts

Life insurance

Job summary

An established industry player is seeking a skilled professional to tackle complex operational challenges in the pharmaceutical sector. This role involves driving process improvements, ensuring compliance with regulatory standards, and leveraging data analytics to enhance manufacturing operations. You will lead initiatives focused on Lean principles and Six Sigma methodologies, while also mentoring teams on best practices. Join a dynamic environment where your expertise will directly impact efficiency and quality in production. If you are passionate about making a difference and have a strong background in the pharmaceutical industry, this opportunity is perfect for you.

Qualifications

• 5+ years in the pharmaceutical industry with a focus on compliance and quality.
• Bachelor’s degree in a relevant field with strong problem-solving abilities.

Responsibilities

• Develop novel approaches to solve operational problems while ensuring compliance.
• Drive process improvements and manage product transfers and equipment optimization.

Skills

Problem-solving skills

Data analysis

Stakeholder management

Process improvement

Technical support

Education

Bachelor’s degree in Life Sciences, Physical Sciences, Engineering

Tools

Lean Manufacturing

Six Sigma

Aseptic manufacturing equipment

Job description

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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