Manufacturing Technician - Second Shift

Kindeva Drug Delivery is a leading global contract developer and manufacturing organization (CDMO) with delivery platform experience and expertise in autoinjector, inhalation, transdermal/intradermal patch, and nasal spray technologies. The Lexington location develops, manufactures, and commercializes prescription nasal spray products and is experiencing increasing continuous growth. We partner with our customers to improve patient outcomes around the world. Together, as One Team, we will manufacture more tomorrows. If you are ready to work for a purpose, join our team!

Job Summary: The manufacturing technician is responsible for cleaning, sanitizing, operating, and maintaining process equipment used to manufacture sterile nasal spray drug products and for completing the associated documentation.  

Essential Duties:

• Follow Production Batch Records (PBRs) to operate, monitor, and control equipment and process parameters during manufacture.
• Follow SOPs to clean, sanitize, and prepare process equipment for manufacturing.  Follow SOPs to clean and sanitize rooms as required.
• Complete PBRs, Logbooks, Forms, and other documentation.  Assist in the compilation and review of lot records before submitting to QA.
• Write and revise SOPs and Forms to accurately reflect the current procedures.
• Maintain assigned manufacturing area neat, clean, and well stocked with supplies
• Assist with the training of other manufacturing team members.
• Coordinate manufacturing, calibration, and maintenance activities with other departments.
• Assist with the writing, executing, and reviewing validation protocols for manufacturing/support equipment.
• Independently champion manufacturing or facility-related improvement projects.
• Participate in the performance of routine preventive maintenance on facilities and equipment.
• Help identify continuous improvement and cost savings opportunities.
• Adhere to cGMPs, SOPs, and Safety policies.
• Other duties as assigned.

Candidate Attributes:

• Excellent organizational skills and attention to detail.
• Strong interpersonal and communication skills.
• Motivated to perform work while maintaining a focus on long-term learning and self-improvement.
• Must be flexible, adaptable, self-motivated, and able to work well independently and across teams and partners.
• Ability to work in a lean, action-oriented organization and demonstrate a strong work ethic
• Good written communication skills to read and write SOPs and complete documents.
• Pharmaceutical experience is preferred.
• Experienced with Microsoft Word and Excel.

Qualifications

• High School diploma or GED.
• 0 - 5 years of applicable experience working in a 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 demands/qualifications:

• Employees are required to regularly use hands in order to execute documentation, setup and operate equipment, and handle materials. 
• Employee is required to regularly stand and walk for extended periods of time.
• Employees must occasionally lift and or move up to 60 pounds.
• Specific vision abilities requirements include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust and focus.
• Employees are required to wear all required Personal Protective Equipment.
• Ability to use proper lifting techniques and be conscious of the work area hazards.
• Employees are required to follow all cGMP and safety procedures.

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