Description
Overview
The Crosslink Manufacturing Technician is responsible for executing the activities and procedures required for the production of cross-linked hyaluronic acid products. This role operates under close supervision, adhering to established procedures to ensure compliance with safety, quality, and regulatory standards.
Key Responsibilities
Production Operations
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Operate production equipment in accordance with Standard Operating Procedures (SOPs), Batch Records, Manufacturing Directions (MDs), and Operating Procedures (OPMs).
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Execute procedures associated with cross-linked hyaluronic acid product manufacturing.
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Perform scheduled equipment cleaning and sterilization.
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Carry out solvent recovery and equipment cleaning (Clean-In-Place, Clean-Out-of-Place) for complex systems and components.
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Assist with troubleshooting and resolution of process-related issues.
Documentation & Compliance
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Record data accurately in Batch Records, logbooks, and OPMs.
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Document all work activities following Good Documentation Practices (GDP).
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Report procedural deviations and nonconformances to management.
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Maintain current training on all assigned procedures, including classroom, skills-based, and “read & understood” training requirements.
Job Complexity
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Work assignments are routine in nature and require knowledge of cGMP practices.
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The role typically involves detailed instruction for daily tasks, with training provided for new assignments.
Required Qualifications
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High school diploma, GED, or equivalent experience.
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0–1 years of related experience in a manufacturing environment.
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Flexibility to work varied hours to meet production needs.
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Strong written and verbal communication skills.
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Ability to gown and work in biotechnology/pharmaceutical manufacturing areas.
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Ability to wear personal protective equipment (PPE), including safety glasses, gloves, and safety shoes.
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Physical ability to:
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Lift, pull, or push 25–50 lbs.
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Stand for extended periods (up to 6 hours).
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Climb ladders and access elevated platforms.
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Comfortable working around chemicals (e.g., alcohols, acids, bases).
Desired Qualifications
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Prior manufacturing experience in the medical device industry.
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Experience working in cleanroom environments or with aseptic techniques.
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Familiarity with commercial-scale automated equipment.
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Ability to perform computerized transactions and maintain spreadsheets.