1st/2nd Shift Available-$20/hr.

Job Description

The Cleanroom Technician supports daily production and packaging activities in a regulated manufacturing environment, following Good Manufacturing Practices (GMP) and standard operating procedures (SOPs). This role focuses on achieving production goals, performing in-process quality checks, maintaining accurate documentation, and operating cleanroom equipment and systems to ensure timely, high-quality product release.

Responsibilities

• Perform daily production and packaging activities in accordance with Good Manufacturing Practices (GMP) and all related standard operating procedures (SOPs).
• Work consistently to achieve assigned production goals and respond to unscheduled peaks in workload to ensure timely release of product and prevent back orders.
• Collaborate with team leaders and other stakeholders to understand critical raw materials, in-process procedures, and specifications.
• Assist in identifying and implementing corrective actions for technical problems related to raw materials and finished products.
• Perform in-process quality checks on sub-assemblies and finished products to ensure they meet specifications.
• Identify line issues and other production problems and promptly notify the team leader or appropriate personnel of required corrective actions.
• Maintain accurate records and documentation in accordance with Good Documentation Practices (GDP) and all related SOPs.
• Use a computerized Materials Resource Planning (MRP) or Enterprise Resource Planning (ERP) system to report lot-controlled ingredients on batch records and to support inventory accuracy.
• Perform line clearances and verify that equipment, materials, and documentation are correctly set up and cleared before and after production runs.
• Operate production and packaging machinery safely and efficiently, including set-up, basic troubleshooting, and routine checks.
• Support qualification and validation activities as needed by following established protocols and documenting results.
• Follow Good Laboratory Practices (GLP) and comply with FDA and ISO requirements as applicable to the manufacturing process.
• Contribute to a safe and clean cleanroom environment by following gowning, cleanliness, and safety procedures at all times.
• Assist in training and supporting new team members on processes, equipment, and documentation requirements, especially at higher technical operator levels.
• Close work orders accurately and on time, ensuring all associated documentation and system entries are complete and compliant.

Essential Skills

• At least four years of previous assembly or packaging experience, preferably in a regulated medical device manufacturing or pharmaceutical environment.
• Strong understanding of Standard Operating Procedures (SOPs), including what SOPs are, why they are important in manufacturing, and how to follow them to achieve production and quality goals.
• Ability to clearly explain past experience using SOPs, including detailed examples of how they were followed in previous roles.
• Solid understanding of Good Documentation Practices (GDP), including what GDP is and how to maintain accurate, compliant records.
• Experience performing line clearances, with the ability to describe accurate examples of how line clearances were completed in past positions.
• Hands-on experience with machine operation in a production or packaging environment.
• Experience with quality assurance activities such as in-process inspections and final checks on sub-assemblies and finished products.
• Experience in packaging and inspection in a manufacturing setting.
• Basic computer operation skills for use with production systems and documentation.
• Knowledge of Good Manufacturing Practices (GMP) and their application in daily production activities.
• Previous experience with, or the ability to quickly comprehend, coagulation-based manufacturing processes.
• Familiarity with GDP, GMP, Good Laboratory Practices (GLP), FDA, and ISO requirements.
• Ability to use or learn Materials Resource Planning (MRP) and large Enterprise Resource Planning (ERP) systems, such as SAP or similar.
• Strong reliability and attendance, with the ability to support production without creating process bottlenecks.
• Willingness and flexibility to work overtime, including occasional Saturdays, as required by production needs.

Additional Skills & Qualifications

• Knowledge of qualification and validation trials and the ability to support these activities is a plus.
• Working knowledge of M