Technician - I (Continental)
Sun Pharmaceuticals, Inc
**General Summary:**
Cleaning & sanitizing packaging and compounding equipment and GMP working areas according to applicable SOPs. 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 (CAPAs)
+ 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 SOPs required to be in compliance with cGMPs.
+ 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
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.
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