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