Manufacturing Specialist

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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.

$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.

Mid-Senior level

Contract

Industries

Staffing and Recruiting