Job Description
Validation & Engineering Group, Inc. (V&EG) is a leading service provider offering solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in areas such as Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.
We are seeking a talented, dedicated individual committed to the highest ethics standards for the following position:
- Inspection & Packaging Operator I
MAJOR DUTIES AND RESPONSIBILITIES:
- Operate automatic and semi-automatic inspection equipment following all established cGMPs and safety regulations, maintaining equipment uptime and minimizing downtime. Perform manual and semi-automated inspection for liquid and lyophilized products, including syringes.
- Operate automatic and semi-automatic packaging equipment following all established cGMPs and safety regulations, maintaining equipment uptime and minimizing downtime. Perform manual and semi-automated packaging and syringes combination product assembly when necessary.
- Clean all packaging, assembly, and inspection lines according to procedures as needed.
- Verify components against the packaging process order.
- Complete accurate (error-free) documentation required before line startup and during the packaging process, following good documentation practices and delivering it on time.
- Perform housekeeping and handle waste according to procedures.
- Inspect the quality and accuracy of all data printed during inspection, assembly, and packaging processes.
- Detect discrepancies during packaging, perform reworks or re-inspections as required by procedures.
- Attend all mandatory training meetings for cGMPs, EHS, and company policies.
- Participate in special projects, audits, regulatory inspections, and assist manufacturing activities in other areas within operations as needed.
KNOWLEDGE:
- High School Diploma
- At least One (1) year of experience within the pharmaceutical industry.
- Knowledge in operating inspection, assembling, and packaging equipment such as:
- 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 equipment
- Accurate visual inspection skills (e.g., defect detection in products and components)
- Knowledge of cGMP practices, process areas, documentation, safety, EHS, and hygiene practices
- Good communication and interpersonal skills
- Basic knowledge of computerized systems
- Good leadership and commitment
- Ability to enter data into a computer and perform process transactions
- Ability to operate pallet jacks
- Willingness to work irregular hours, rotating shifts, weekends, and holidays when necessary
- *Candidate must pass the sight screening test established within the Quality Assurance or Packaging SOP