Title:  Technician I

Technician - I

General Summary:

Cleaning & sanitizing packaging and compounding equipment and GMP working areas according to applicable SOP’s.  May also be required to conduct duties of a Line Service Technician by operating filling and packaging equipment in a safe manner while maintaining compliance with cGMP and SOP requirements. 

Principal Duties and Responsibilities:  

• Wash and sanitize miscellaneous and product contact parts for filling and compounding equipment
• Maintain the wash up room in a clean and sanitary condition.
• Clean and sanitize GMP areas according to applicable SOPs
• Maintain miscellaneous and sanitization supplies
• Complete all applicable documentation such as cleaning & sanitizing records and logs.
• Assist with staging of raw materials and equipment parts
• Assist custodial staff with cleaning of the premises.
• Equipment set up as assigned
• Complete G.M.P. documents right first time, such as the cleaning & sanitization records, non-stationary equipment logs and batch records
• Complete all GMP Documentation correctly and in a timely manner
• Complete all training assignments and maintain personal training records
• Participate in and/or lead Non Conformance Investigations
• Complete Corrective and Preventive Actions (CAPA’s)
• Initiate, and follow through with actions required to close Change Controls
• Participate in Internal, Customer and Regulatory Audits.

Other duties and responsibilities:

• Work with safety in mind with respect to all assigned tasks
• Supply filling lines with components and bulk for packaging
• Ensure drum and lot changes are completed effectively and on time with minimal bulk waste
• Monitor and adjust fill weights throughout the operation ensuring minimal overfill
• Assemble and disassemble equipment such as fillers, manifolds, tube holders and supply pumps
• Perform line changeovers, set up and troubleshooting
• Prepare detergent and sanitizing agents with the correct dilution factor
• Sanitize filling rooms as per standard operating procedure
• Perform housekeeping tasks such as washing floors, walls etc.
• Participate in Line Clearance Processes both inside filling rooms and in packaging
• Wash and sanitize wetted change parts for fillers and supply pumps
• Operate filling units and cartonners as required
• Troubleshoot rapidly and effectively to ensure minimal line downtime
• Assist with training of new hires
• Ensure all measures are in place and procedures followed to prevent contamination of the filling room, bulk products and equipment
• Support line leader to ensure smooth operation and execution of shop order
• Assist Line Mechanics as required
• Other duties as assigned

Knowledge, Skills and Abilities:

• Must be able to add subtract, divide multiple, calculate average and percentages.
• A good working knowledge and understanding of SOP’s required to be in compliance with cGMP’s.
• Good communication skills, written and verbal, in order to communicate effectively with operations personnel.
• Minimum Grade 12 education or equivalent
• 2 years experience in a pharmaceutical or related industry.
• Excellent math skills.
• Fluent in English (verbal, reading and writing skills),
• Excellent interpersonal skills.
• Mechanical aptitude.

Background and Experience:

• Pharmaceutical experience is an asset
• Experience with mechanical set-ups on the packing, filling, process in a pharmaceutical, food or similar GMP environment
• Fork lift certification an asset
• WHMIS training an asset
• Ability to use a computer and Microsoft software

Problem Solving:

• May be requested to assist with a cleaning procedure when new equipment is introduced to the floor.
• Able to resolve minor difficulties such as starting and stopping fillers, clearing “ jam – ups “.
• Typically when a problem arises the line leader, line mechanic and or supervisor will be able to assist.

Working Conditions:

• A significant time will be spent washing and sanitizing equipment resulting in exposure to water, cleaning agents and a high humidity environment.
• Ability to able to stand for long periods of time.   Also, bend, squat and walk throughout the day.
• Ability to safely lift up to 60 lbs.
• Operate lifting devices such as drum lifters, pallet trucks and pallet wrappers.
• Overtime will be required. This may be additional time during the workweek and / or on weekends.
• Unless pre-arranged the position is considered to be a “rotational shift “ based on 37.5 hours per week.
• GMP garments required to be worn within the manufacturing environment