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CINCO Engineering logo
CINCO Engineering

We help Life Sciences protect their patients by managing the risks on their manufacturing processes.

Manufacturing Specialist

OperationsOperationsFull TimeRemoteMid LevelTeam 1-10Since 2004H1B No SponsorCompany SiteLinkedIn

Location

United States

Posted

75 days ago

Salary

0

Seniority

Mid Level

Job Description

Manufacturing Specialist

CINCO Engineering

Role Description With minimal supervision, support the execution of manufacturing/quality systems such as non-conformances, process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. May serve as primary production process owner for process support systems and assist with process ownership responsibilities on more complex process systems. Qualifications - Experience in manufacturing, process development, or quality assurance in the Biotech or pharmaceutical industry with progressively increasing responsibility. - Demonstrated experience in compliance, problem solving, critical thinking, project management, and quality systems. - Proficient and experienced in owning Change Controls. - Project Management and/or Quality Management skills and experience. - Excellent communication skills, both written and verbal (including technical writing and presentation skills) in English. - Demonstrated ability to work autonomously, present data in an organized and logical manner, meet deadlines, prioritize work, and communicate effectively. - Proficient with Microsoft Office Tools (Word, Excel, PowerPoint, Project, Teams, Outlook). - Experience managing quality records (deviations, CAPAs, CAPA-EV, Change Controls, Supplier Investigation Records) using TrackWise, Vevaa, or a comparable quality system. - Experience navigating and executing transactions in SAP (ERP) system. - Strong negotiation skills when working with external suppliers and internal team members. Requirements - Initiate, revise, and approve manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner. - Assess process performance by observation of floor operations and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities. - Support establishment of process monitoring parameters and control limits. Collect process-monitoring data and support the assessment of deviations. - Responsible for managing NC/CAPA closure within established goals. - Review equipment/system Root Cause Analysis investigations and support trend evaluations. - Assist with generation of process validation protocols and reports. - Participate in the NPI process to assess requirements for documentation, materials, training, and equipment modifications. - Assist manufacturing change owner on CCRB packages impacting the process. Education - Bachelor's degree and 5 years of Manufacturing Operations experience or associate’s degree and 10 years of Manufacturing Operations experience.

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