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:

• Inspection & Packaging Operator I

MAJOR DUTIES AND RESPONSIBILITIES:

1. Operates automatic and/or semi-automatic inspection equipment following all established cGMP’s and Safety regulation maintaining equipment's up time and running to reduce downtime to a minimum. Performed manual and semi-automated inspection for liquid and lyophilized products, including syringes.
2. Operates automatic and semi-automatic packaging equipment following all established cGMP’s and Safety regulation maintaining equipment's up time and running to reduce downtime to a minimum. Performed manual and semi-automated packaging and syringes combination products assembly process, when necessary.
3. Cleans all packaging/assembly/inspection lines according to procedures, as needed.
4. Verifies components against the packaging process order.
5. Completes area accurate (error free) documentation required before line star up and during the packaging process, following good documentation practices and delivers it on time.
6. Performs housekeeping and handling of waste according to procedure.
7. Inspects the quality and accuracy of all data printed during the inspection/assembly/packaging processes.
8. Detects discrepancies during the packaging process, performs reworks/re-inspection as required by procedures.
9. Attends to all mandatory training meetings for cGMPs, EHS and company policies.
10. Participates in special projects and during audits and regulatory inspection and assists manufacturing activities in other areas within operations, as required.

KNOWLEDGE:

• High School Diploma
• At least One (1) year of experience within pharmaceutical industry.
• Knowledge in operating the following inspection/assembling/packaging equipments:
  • Manual inspection booths, Semi-automated inspection equipment (e.g. V-90 Seidenader)
  • Labeler machines for Parenteral products
  • Cartoner machines
  • Check weigher and/or scales
  • Electronic equipment
  • Vision systems
  • Manual assembly/packaging lines
  • Secondary packaging semi-automated equipment
  • Combination product assembly equipments.

• Accurate visual inspection (e.g. products and components defects)
• Knowledgeable in CGMP practices, process area, documentation, safety, EHS and hygiene practices.
• Good communication and Interpersonal skills
• Basic knowledge on computerized system.
• Good leadership and commitment
• Ability to enter data into a computer and perform process transactions.
• Ability to operate pallet jacks.
• Willing to work irregular hours, rotative shifts, weekends and holidays when necessary.
• *The candidate must approve the sight screening test established within the Quality Assurance or Packaging Standard Operating Procedure (SOP).

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