Job Description

Job Description

Job Description

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Quality - Cleaning & Support Technician

MAJOR DUTIES AND RESPONSIBILITIES:
1. Perform daily operation cleaning, sanitization and decontamination of the Parenteral Manufacturing Areas and equipment :

• Cleans and sanitizes sterilize manufacturing area rooms and equipment.
• Documents the cleaning process following the good documentation practices.
• Sterilizes equipment to be used in the cleaning process by operating an autoclave.
• Prepares germicide and sporocidal solutions as per SOP.
• Filtrates isopropyl alcohol 70%, when necessary.
• Maintains inventory and request all necessary components and operating materials in order to assure continue operations.
• Completes preparation of cleaning equipment used for production activities.
• Maintains good communication with support departments in order to comply with all the manufacturing needs.
• Performs fogging process with sporocidal solutions through the Air handling Unit ducts.
• Checks and verifies manufacturing equipment, installation, calibration, and connections.
• Tests the filter bubble point before and after the IPA filtration process.
• Cleans and unloads the autoclave every week.
• Completes all required production documentation in a legible, error free and on time manner following good documentation practices.
• Attends to all mandatory training meetings for cGMP’s, EHS and Company Policies.
• Coordinates, checks and verifies all manufacturing equipment installation, calibration and connections.

2. Performs duties related to support other areas as required by the supervisor

• Attends and actively participate in meetings and trainings for department communication, safety, security, and quality.
• Participates in production scheduling meeting.
• Follows up on progress of activities (e.g. documentation approval) with support departments and inform status to the supervisor.
• Assists other areas within operations and at the site.

3. Performs Environmental Health and Safety duties required by the job as follow

• Maintains housekeeping within controls and aseptic environments, according to procedures.
• Handles Hazardous and Non-hazardous waste according to EHS procedures.
• Supports Environmental Monitoring Program by assuring sampling collection within manufacturing area on established timeframe.
• Supports Annual Requalification Program by assuring plan execution on established timeframe.
• Maintains the reusable garment program inventory control.

KNOWLEDGE/ EDUCATION/ EXPERIENCE:

• High School Diploma
• One (1) year experience in Parenteral or manufacturing processes Knowledge of Aseptic Processing Technical skills.
• Understanding of basic science concepts as applicable to the process/product and their impact in product quality.
• Proficiency using computer, software, and/or automated equipment as related to assigned functions.
• Willing to learn new Computerized, PLC control equipment, procedures and new scientific processes.
• Ability to collect numerical data and skill in basic mathematical applications (basic calculations such as additions, subtractions, multiplication, division, rounding, average and yields)
• Ability to maintain housekeeping and handles waste according to procedures.
• Ability to maintain daily production and labor data in computerized system.
• Ability to follows the daily production schedules.
• Basic knowledge in steam sterilization, depyrogenation, filtration sterilization, lyophilization preferable.
• Knowledgeable in cGMP’s, process area, documentation, safety, EHS and hygiene practices.
• Ability to work with minimum supervision, take decisions to resolve day-to-day problems in accordance with regulations and internal procedures.
• Ability to communicate via multiple channels and with varied audiences ( team members, FDA, EMEA, OSHA, senior leaders).
• Ability to read procedures and documents in English/Spanish Text (e.g. SOPs, Batch Records, etc.)
• Ability to operate pharmaceutical manufacturing equipment.
• Skill in navigating through and performing transactions in mfg computer systems (HMI, hand held computers).
• Knowledge of the basic theory supporting environmental monitoring and in process test and impact of results in product quality.
• Understand the impact of temperature, humidity and pressure control and monitoring within an aseptic area. Has knowledge of room classification criteria and specific room’s classification.
• Strong organizational skills.
• Able to wear sterile gowns, full face mask, and full face respirators where required, use Latex/Nitrile Gloves and disposable uniforms.
• Able to move objects such as lifting, carrying, pushing and pulling (25-60 pounds).
• Willing to work irregular hours, rotative shifts, weekends and holidays when necessary.
• Ability to operate pallet jacks.

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