JOB SUMMARY

The Pharmaceutical Manufacturing Technician will be responsible for the cGMP production of APIs and intermediates and will function as a primary or secondary operator. This role requires consistently following safety protocols, maintaining clean production areas, and operating production equipment during production, cleaning, and maintenance. The technician will communicate production status effectively and participate in a team-based, multi-shift manufacturing environment, actively engaging in inter-shift communication and maintaining high-quality in-lab housekeeping.

Key Responsibilities

• Consistently follow and actively promote proper safety protocols and PPE to other staff.
• Maintain the safety and cleanliness of production areas and all related equipment during each shift, specifically maintaining potent compound handling techniques.
• Utilize a wide variety of written procedures, including batch records and existing operating procedures.
• Function as a primary or secondary operator for cGMP production of APIs and intermediates.
• Effectively operate production equipment during production, cleaning, and maintenance as necessary to support production operations.
• Communicate production status effectively through shift pass-off tools.
• Correct safety and process issue gaps as identified through standard inspections and audits in a timely and effective manner.
• Participate in a team-based, multi-shift manufacturing environment by actively engaging in inter-shift communication and maintaining high quality in-lab housekeeping.
• Provide departmental support through additional tasks as directed by department leadership.
• Work with highly potent / hazardous materials.
• Set-up and calibrate equipment for operation and testing to specifications
• Adjust filler and labeler equipment with proper parts and settings for products to be portioned
• Assemble containers and components for portioning process and ensure correctness.
• Conduct housekeeping tasks following set-up (including disinfection and autoclaving, as required) to assure cleanliness of assembled equipment
• Sign in for bulk containers and lot number verification to paperwork
• Order and stock necessary supplies to support operations
• Portion materials into containers under safe production conditions
• Assemble and don required safety equipment specified by protocol
• Follow-up on inventory shortages
• Verfiy quantities for accuracy (cases vs box vs EA)
• Set up, operate, and troubleshoot all automated labeling and bagging equipment
• Check and update mainframe systems and SAP as required
• Maintain records for accountability and procedure traceability
• Document all data for traceability of bulk and components
• Record all tests, measurements and calibrations required during operations
• Record all calculations and conversions necessary to process paperwork
• Clean and maintain equipment/work area to assure product integrity
• Clean packaging equipment, test equipment, tools-disassembling if required
• Clean workstations and restock all materials storage areas and document cleaning on area/hood cleaning log
• Share ideas for improvement including common sense ways to save money
• Participate in testing and implementation of changes
• Wear the appropriate personal protective equipment inclusive of steel-tied safety shoes
• Maintain, clean, and keep safe all work areas and equipment
• Maintain personal protective equipment
• Take necessary steps to assure we provide our customers with the highest quality possible
• Immediately report any situation that could compromise safety or quality
• Perform miscellaneous duties and tasks as assigned
• Maintain exemplary attendance and adherence to schedule

Required Qualifications

• Associate degree in Chemistry, Biochemistry, Chemical Engineering, or related Life Science -OR- High School Diploma or GED equivalent.
• 2+ years of pharmaceutical, chemical, or related production manufacturing experience.
• Ability to read and understand written protocols.
• Basic computer literacy (Microsoft Word, PowerPoint, Email, etc.).
• Effective oral and written communication skills.
• Mechanical aptitude.
• Able to operate hand tools, calculators and weighing / measuring devices.
• Basic mathematical skills - including metrics and conversions.
• Possess a high degree of motivation and are a self-starter.
• Ability to multi-task while paying close attention to detail.
• Able to stand for long periods of time.
• Must be able to lift and move up to 50 pounds with the assistance of equipment or teammates as necessary.
• Knowledge of safety rules, FMP, SOP's, UOP's
• Eye-hand coordination
• Legible handwriting
• Teamwork and problem-solving skills
• Able to train others
• Ability to use hand and air tools, pumps, and an electronic scale and to operate material handling equipment.
• Ability to identify problems
• Ability to read instructions and understand oral and written instructions.

Preferred Qualifications

• College course work in chemistry or 6 months previous experience weighing chemicals.