Kindeva Drug Delivery
Manufacturing Technician - Formulation & Fill (Third Shift)
Kindeva Drug Delivery, Lexington, Kentucky, us, 40598
Manufacturing Technician - Formulation & Fill (Third Shift)
Join to apply for the
Manufacturing Technician - Formulation & Fill (Third Shift)
role at
Kindeva Drug Delivery If you are ready to work for a purpose, join Kindeva Drug Delivery! Working on the KDD Manufacturing Team as a Manufacturing Technician in Formulation & Fill, you will play a crucial role in supporting the manufacturing of life-changing and life-saving prescription nasal spray medications. Responsibilities
Follow Batch Records to operate, monitor, and control equipment and process parameters during manufacture. Complete training and follow Standard Operating Procedures (SOPs) to clean, sanitize, and prepare process equipment and production rooms for manufacturing. Cross-trained in multiple manufacturing unit operations. Accurately complete all required Good Manufacturing Practice (GMP) documentation. Maintain assigned manufacturing area(s) in accordance with 5S. Training and onboarding of new manufacturing team members. Assist with the execution of validation protocols for manufacturing/support equipment. Participate in the execution of routine preventive maintenance on facilities and equipment. Troubleshoot and elevate equipment and/or personnel issues impacting manufacturing. Recommend manufacturing process or facility-related improvements, and cost savings opportunities. Key Manufacturing Duties
Operate and monitor production equipment following PBRs and SOPs Clean and maintain manufacturing areas, equipment, and facilities Complete and review production documentation, including batch records and logbooks Train team members and coordinate with other departments Assist with validation protocols and improvement projects. Lead improvement projects and identify cost‑saving opportunities Ensure compliance with cGMPs, SOPs, and safety protocols Qualifications
High School diploma or GED. 2+ years of applicable experience working in a GMP pharmaceutical manufacturing environment. Experience with sterilization processes or aseptic technique preferred. Good written communication skills to write SOPs and other cGMP documents. Qualified to work with controlled substances. Strong interpersonal skills and the ability to work well in a team environment. Physical Requirements
Employee is required to regularly use their hands to handle materials and supplies. Employee is required to use computers for an extended period each day. Employee is required to effectively use communication by both telephone and electronic. Employee is required to regularly stand and walk for extended periods of time. Employee must occasionally lift and or move up to 25 pounds. Ability to use proper lifting techniques and be conscious of the work area hazards. Employee must have adequate vision to be able to read and execute documentation and perform job tasks compliantly and safely. Employee is required to follow all site safety procedures. Occupational exposure/ Risk potential: The work environment includes the ability to work with high-potency chemical compounds, hazardous materials, toxic substances, and controlled substances. Must be willing to adhere to stringent PPE requirements, safe work methods, and practices to ensure safety and quality for personnel and finished product. Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. California residents should review our Notice for California Employees and Applicants before applying. Referrals increase your chances of interviewing at Kindeva Drug Delivery by 2x Georgetown, KY $38.93 - $44.70 3 months ago
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Join to apply for the
Manufacturing Technician - Formulation & Fill (Third Shift)
role at
Kindeva Drug Delivery If you are ready to work for a purpose, join Kindeva Drug Delivery! Working on the KDD Manufacturing Team as a Manufacturing Technician in Formulation & Fill, you will play a crucial role in supporting the manufacturing of life-changing and life-saving prescription nasal spray medications. Responsibilities
Follow Batch Records to operate, monitor, and control equipment and process parameters during manufacture. Complete training and follow Standard Operating Procedures (SOPs) to clean, sanitize, and prepare process equipment and production rooms for manufacturing. Cross-trained in multiple manufacturing unit operations. Accurately complete all required Good Manufacturing Practice (GMP) documentation. Maintain assigned manufacturing area(s) in accordance with 5S. Training and onboarding of new manufacturing team members. Assist with the execution of validation protocols for manufacturing/support equipment. Participate in the execution of routine preventive maintenance on facilities and equipment. Troubleshoot and elevate equipment and/or personnel issues impacting manufacturing. Recommend manufacturing process or facility-related improvements, and cost savings opportunities. Key Manufacturing Duties
Operate and monitor production equipment following PBRs and SOPs Clean and maintain manufacturing areas, equipment, and facilities Complete and review production documentation, including batch records and logbooks Train team members and coordinate with other departments Assist with validation protocols and improvement projects. Lead improvement projects and identify cost‑saving opportunities Ensure compliance with cGMPs, SOPs, and safety protocols Qualifications
High School diploma or GED. 2+ years of applicable experience working in a GMP pharmaceutical manufacturing environment. Experience with sterilization processes or aseptic technique preferred. Good written communication skills to write SOPs and other cGMP documents. Qualified to work with controlled substances. Strong interpersonal skills and the ability to work well in a team environment. Physical Requirements
Employee is required to regularly use their hands to handle materials and supplies. Employee is required to use computers for an extended period each day. Employee is required to effectively use communication by both telephone and electronic. Employee is required to regularly stand and walk for extended periods of time. Employee must occasionally lift and or move up to 25 pounds. Ability to use proper lifting techniques and be conscious of the work area hazards. Employee must have adequate vision to be able to read and execute documentation and perform job tasks compliantly and safely. Employee is required to follow all site safety procedures. Occupational exposure/ Risk potential: The work environment includes the ability to work with high-potency chemical compounds, hazardous materials, toxic substances, and controlled substances. Must be willing to adhere to stringent PPE requirements, safe work methods, and practices to ensure safety and quality for personnel and finished product. Equal Opportunity Employer
Kindeva Drug Delivery is an Equal Opportunity/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, gender, age, national origin, disability, Protected Veteran status, sexual orientation, or any other characteristic protected by federal, state or local law. California residents should review our Notice for California Employees and Applicants before applying. Referrals increase your chances of interviewing at Kindeva Drug Delivery by 2x Georgetown, KY $38.93 - $44.70 3 months ago
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