Position Summary:
Reporting to the Production Supervisor, the Material Prep Technician is responsible for dispensing and compounding raw materials in accordance with Master formulas and standard operating procedures, and the cleaning of equipment in accordance with Standard Operating Procedures (SOPs) to ensure compliance with Good Manufacturing Practices (GMPs).
Duties and Responsibilities:
Utility Activities:
Responsible for the delivery of fill and gel receivers to encapsulation.
Assemble, disassemble, rinse, scrub, clean and disinfect equipment in accordance with SOPs. Equipment includes, but is not limited to: fill tanks, lids, tumbler baskets, valves, hoses, carboy containers, stainless steel pots, spreader boxes, pumps, mixing heads and mixers.
Inspect equipment for cleanliness and damage.
Load/Unload equipment in designated washer.
Rinse equipment using IPA squirt bottle.
Spray equipment with air hose.
Apply clean tag on equipment and bag as required.
Transfer clean equipment to designated areas.
Prepare cleaning solutions as required.
Perform daily and weekly sanitation of the utility area and applicable equipment.
Assist departments in maintaining cleanliness, may include disposing of scrap materials.
Scraping gel on equipment and floor.
Transferring garbage to warehouse.
Gel Manufacturing Activities:
Retrieve raw material drums from staging area and transports them to weigh room.
Use the appropriate scale to weigh quantity (verify that scale has been checked for accuracy).
Prepare a dispensing ticket for each ingredient and each lot.
A second authorized individual will observe each step in the dispensing process and verify that all steps are completed accurately and in accordance with formula master instructions.
Transfer weighed raw material from the gelatin dispensing room to the preparation room.
Prepare tanks to drain gel from gel melter (inspect for cleanliness, assemble valve to tank, weigh tanks).
Return empty and partial raw material containers to the appropriate location in the staging area.
Enter data into computer to generate gel formulas and colourant formulas in accordance to schedule requirements.
Execute steps to prepare and /or colour gel mass in accordance to master formula instructions and standard operating procedures.
Perform daily and weekly sanitations of the gel melter tanks and processing rooms.
Fill Compounding Activities :
Communicate with operator from previous shift – during shift change, regarding necessary facts and current events related to the daily operations.
Input data into the specified software and print the required labels/forms.
Maintain the equipment used and the working areas clean and organized at all times.
Compound raw materials in accordance to master formula instructions and standard operating procedures.
Check and dispense raw materials as required in Master formulas.
Clean and prepare equipment and preparation rooms for batch processes in accordance to Good Manufacturing Practices.
Drain and deaerate fill material batches as required and in accordance to standard operating procedures.
Weigh and transport fill tanks to their staging areas as required by schedule.
Dispensing activities:
Request and stages raw materials as required.
Dispense raw materials in accordance to Master formulas and standard operating procedures.
Retrieve raw materials, from the warehouse as required.
Clean and prepare equipment/compounding dispensing rooms for batch processes in accordance with GMPs.
Common duties:
Comply with all SOPs and GMPs.
Participate in GMP inspection audits and process investigations as required.
May be asked to work extended hours (overtime), especially when problems occur or when deadlines must be met.
Perform other duties as required.
Completes all documentation as required.
Assist with training of employees
The Candidate:
Education:
High School Diploma
Experience:
1-3 years of experience in a manufacturing, pharmaceutical, and/or GMP Facility
Skills Required:
Strong mathematic skills in order to compute simple calculation (adding, subtracting, multiplication, division, percent, and averages).
Ability to stand for long periods of time.
Possess a high degree of attention to detail and accuracy
Good communication (written and verbal), and interpersonal skills
Working Conditions:
While performing the responsibilities of the job, these work environment characteristics are representative of the environment the employee with encounter. Reasonable accommodation may be made to enable people with disabilities to perform the essential functions of the job.
The noise level in the work environment is usually moderate to high.
Position is located in Windsor, Ontario.
Regular working hours: 12 hour continental shifts.
Catalent offers rewarding opportunities to further your career! Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference.
Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone’s safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.
personal initiative. dynamic pace. meaningful work.
Visit www.catalent.com/careers to explore career opportunities.
C atalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation or gender identity. If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected] . This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.
Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.
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