Work Schedule
Rotational shift nights/weekends
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards
Job 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