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:

• Biologics Support Operator I

Purpose:
Perform cleaning, sterilization, weighing and dispensing of materials. Monitor alarm systems. Assemble and
inspect equipment in the manufacturing area to confirm operational status. Work is performed in aseptic or
non-aseptic environments. Perform process tests and participate in qualification and validation activities as
required.

Responsibilities:

• Inspect manufacturing equipment to monitor that performance is within parameters.
• Clean and sterilize equipment for manufacturing use.
• Monitor manufacturing processes using electronic or manual systems and elevate any deviation that could impact the operations to address accordingly.
• Sample collection and processing as required by the process.
• Conduct equipment and facility inspections and advise of situations that affect operating and environmental conditions.
• Receive, inspect and verify materials availability to be used for production.
• Document, audit and timely correct manufacturing electronic or paper batch record discrepancies.
• Document process and equipment status in the area electronic or manual records.
• Audit documentation of operational activities and document discrepancies using computerized or manual systems.
• Strict adherence to current Good Manufacturing Practices (cGMP’s), Standard Operating Procedures (SOP) and accurately complete process-associated documentation.
• Provide assistance to operations in accordance with environmental management, occupational health and safety (EHS) systems and promote continuous improvement. Comply with all EHS procedures and policies including incident reporting, use of PPE, waste management and disposal, and any other program applicable according to the position duties.

Qualifications:

• Associate Degree in Science, Mechanics, Electricity, Instrumentation or related field.
• No previous experience required.
• Basic knowledge of laboratory techniques.
• Basic knowledge of computerized systems such as Delta V, MES and SAP preferred.
• Basic mechanical and mathematical skills.
• Basic verbal and written communication skills in English and Spanish.

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