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Responsible for performing different parenteral manufacturing operations of highly sensitive pharmaceutical/biologics products and equipment. Performs necessary set-ups, and changeovers, equipment cleaning, and line clearance as described in the Standard Operating and Safety Policies and Procedures (SOPs). This position must comply with all Security guidelines, Environmental Health and Safety regulations and the current Good Manufacturing Practices required by the job function.
1. Performs the assigned activities related to the equipment set-ups, changeovers equipment cleaning, and line clearance to achieve an efficient operation of the different processes and products yield maximizing.
Operates and understands the preparation, formulation and filling equipment functions and basic troubleshooting activities Cleans, sanitize, and sterilize manufacturing area rooms and equipments.
Runs autoclaves to sterilize equipment to be used in the manufacturing process
. Performs CIP and SIP (Cleaning in Place and Sterilization in Place) of the tanks.
Performs integrity test of all filters used in the process before and after each use
. Receives, handle, verifies and weigh excipients and drug substance and or active ingredient to be used in the formulation process.
Executes the product formulation as per Batch record and Procedure instructions; this includes pH measurements and adjustments, yield calculations, and volume adjustment.
Performs sampling of bulk solutions as per batch record requirements.
Interacts with computer controlled equipment and processes.
Monitors critical process parameters and proactively takes necessary action to prevent process deviation and/or product losses.
Verifies calibration status of critical instruments before process operation.
Operates in an efficient manner of the manufacturing processes to maximize product yield of products.
Maintains housekeeping within controls and aseptic environments, according to procedures.
Performs systems integrity test such as isolators, ultra filtration skid, distribution systems, filters and gloves as required. Complete production documentation legible, error free and on time following good documentation practices.
2. Ensures the completeness and compliance of all required documentation during the manufacturing process.
Maintains inventory and request all necessary components and operating materials.
Receives, verifies all production records and transaction documents to be error free and in compliance with established procedures, including computer generated transactions.
Completes production documentation legible, error free and on time following good documentation practices.
Audits batch records and documentation, as required. Assures that the Compounding equipment is in good working condition, clean, labeled, and calibrated and/or qualified according to applicable SOPs before performing the formulation process. Revises and improves procedures and develops new SOPs based on observations and experiences.
3. Provides assistance and supports to manufacturing related activities
Initiates, participates, and assists in resolution of quality investigations. Assists in on the job training for new employees.
formulation, equipment preparation, filling, manufacturing technician
Top Skills Details:
Operates manufacturing equipment
Performs necessary set-ups, and changeovers, equipment cleaning, and line clearance
Additional Skills & Qualifications:
High school diploma with, two (2) years of experience in Parenteral Manufacturing Process or three (3) years of experience in pharmaceutical manufacturing process. Knowledge of preparation, formulation and filling processes. Basic writing skills
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.