Work Schedule
Rotational shift nights/weekendsEnvironmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety StandardsJob Description
Position purpose/responsibilities:
Become a key player at Thermo Fisher Scientific Inc. as a Compounding Operator, contributing to groundbreaking scientific advancements.
Specific tasks/primary activities:
Prepare the filling lines within the Sterile Area at the start of production activities and subsequently supervise the accurate product supply.
Perform integrity tests on 0.22-micron sterilizing filters, both hydrophilic and hydrophobic, according to SOPs and Batch Records.
Conduct dissolution and filtration of pharmaceutical products as detailed in Batch Records.
Complete and archive the Batch Record and other related documentation.
Identify raw materials using information systems.
Clean and sanitize reactors and tanks in the Injectable Department, in accordance with SOPs and the weekly production schedule.
Supervise the organization and readiness of items needed to link reactors and tanks, following the weekly production schedule.
Prepare disinfectants for periodic cleaning of Sterile and Pre-sterile Areas.
Coordinate with Supervisors for the entry of production materials using Autoclaves and Pass-throughs.
Ensure materials for reactors and tanks are stored and prepared accurately.
Perform periodic checks on the functionality of machines and equipment.
Sterilize hydrophobic filters on lyophilizers as per SOPs.
Keep up the maintenance of machinery, materials, and the work environment, promptly reporting any irregularities.
Maintain cleanliness in the work environment post-production according to SOPs.
Handle chemical and microbiological sampling, drafting related documentation.
Requirements and qualifications:
(A) ESSENTIAL Education/Diploma/Training Courses:
Scientific diploma or middle school diploma or equivalent experience with proven experience