Manufacturing Technician -Night Shifts

Role Summary

Manufacturing Technician I responsible for routine and critical manufacturing operations across Cell Culture, Purification, Solution & Equipment Prep areas. Operates production equipment per SOPs for clinical and/or commercial products. Reports to Manufacturing Supervisor. Night shift 6:00 PM–6:00 AM, 2-2-3 rotation with weekends and holidays required.

Responsibilities

• Troubleshoot and resolve basic process related issues
• Recognize and escalate deviations
• Execute critical and routine activities in support of production
• Perform Batch Record, Log Book and Form Prep requests
• Enter data in the Laboratory Information Management System (LIMS), MODA and/or other business functions
• Review GMP documentation
• Sample preparation and testing
• Identify changes needed to documentation
• Participate in tiered visual management system and support CI initiatives
• Complete required training on time
• Initiate work orders
• Assemble and disassemble process equipment
• Perform scheduled cleaning of equipment
• Perform standardization of equipment
• Support change over activities
• Execute equipment and process qualifications as well as validation
• Maintain training requirements
• Develop and maintain personal development plan
• Provide annual performance self-assessment on development plan
• Accomplish tasks mainly through direct operation of cGMP activities
• Perform daily operations of the work unit and assist coworkers in fulfilling department goals, elevating issues to senior staff
• Evaluate and elevate issues to senior staff
• Identify process deviations, troubleshoot issues and identify process improvements

Qualifications

• Normally requires a high school diploma and 2+ years of experience or an Associate's Degree in Life Sciences/Engineering with 1 year of GMP Manufacturing experience
• Biotech Certificate preferred
• May be required to serve as subject matter expert for equipment and/or systems
• Proficient at following written instructions in Batch Records, Form Preps, Technical Protocols and Procedures
• Excellent communication and troubleshooting skills
• Full awareness of current Good Manufacturing Practices
• Proficient computer skills
• Basic troubleshooting skills
• Proficient in aseptic technique

Skills

• GMP compliance
• Batch record management
• Equipment qualification and validation
• Data entry into LIMS/MODA
• Problem solving and process improvement
• Communication and teamwork

Education

• High school diploma or equivalent; Associate‚Äôs Degree in Life Sciences/Engineering preferred

Additional Requirements

• Ability to lift/push/pull up to 25‚Äì50 lbs
• Ability to stand for extended periods (up to 6 hours)
• Ability to climb ladders and work on platforms; bending and stooping to troubleshoot
• Ability to work in controlled environments with gowning and protective clothing; potential exposure to chemicals
• Willingness to work multiple shifts, weekends, or supplemental hours as production demands