Manufacturing Technician

Job Description
Overview:

Responsible for cleaning, sanitizing, operating and maintaining process equipment used during the manufacture of company products and for completing the associated documentation. Duties also include cleaning, organizing and monitoring manufacturing clean rooms.

Tasks:

• 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 compilation and review of lot records prior to 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, execution, and review of validation protocols for manufacturing/support equipment.
• Independently champion manufacturing or facility related improvement projects.
• Participate in the performance 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.

Requirements

Qualifications:

• High school diploma or GED
• 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 execute SOPs, PBR's, and cGMP documentation.
• Qualified to work with controlled substances.

Preferred qualifications:

• Pharmaceutical manufacturing experience 0 - 5 years.
• Experienced with Microsoft Word and Excel.
• Associates-Bachelors in a scientific discipline or equivalent experience.
• Experience with clean-room manufacturing and aseptic technique.

Physical demands/qualifications:

• Employee is 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.
• Employee 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.
• Employee is required to wear all required Personal Protective Equipment.
• Ability to use proper lifting techniques and be conscious of the work area hazards.
• Employee is required to follow all cGMP and safety procedures.

Occupational exposure/ Risk potential:

Work environment includes the ability to work with high potent chemical compounds, hazardous materials, toxic 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.