Validation Engineer

United Pharma Technologies - Jersey, GA (30+ days ago)


Validation Specialist

Responsible for supporting equipment qualification and process validation programs including creation and execution of protocols (including sampling and process monitoring) as well as writing/routing/obtaining approval of final reports. The specialist is expected to work cooperatively with Regulatory Affairs, Operations, Quality Assurance, Research & Development and Product Compliance.

Responsibilities:

  • Create and coordinate approval of equipment qualification protocols and reports in line with established validation policies and procedures.
  • Create and coordinate the approval of process validation protocols and summary reports in line with established validation policies and procedures.
  • Create and coordinate approval of cleaning validation protocols/reports and associated documentation in line with established validation policies and procedures
  • Create and coordinate the approval of continued process validation verification plans/reports in line with established validation policies and procedures.
  • Assure validation documentation is available for operation activities.
  • Responsible for assisting in the validation impact assessment regarding changes to validated systems and processes.
  • Troubleshoot/investigate validation-related issues.
  • Maintain completed validation and qualification packages.
  • Execute or assist execution of approved validation and qualification protocols, requiring product monitoring and sampling and also communicating activities.
  • Attend meetings as required to ensure validation activities are tracking to project schedules.

Education:

Required
- High School Diploma / GED
- Bachelor’s Degree

Preferred
- Associate’s Degree
- Master’s Degree or Ph.D.

Experience:

  • 5+ years' experience performing equipment/facilities qualification and/or Process Validation within the Pharmaceutical industry.
  • Working knowledge of various manufacturing process including those used granulation, drying, sizing, blending, compression, encapsulation, coating, printing, and laser drilling.
  • Knowledge of current applicable regulatory standards (FDA, CFR, ICH etc.)
  • Experience in data analysis, technical report writing, root cause analysis, and risk assessment.

Specific Skills:

  • Strong initiative and integrity as well as strong written and verbal communication skills
  • Proficiency with Microsoft Office suite preferred.
  • Proficiency with MiniTab, SAS, or other statistical data processing software preferred.
  • Ability to prioritize, organize, give appropriate attention to detail, and work effectively with minimal supervision including strong follow-up skills, and the ability to provide timely closure of assigned tasks is requireds
  • Competent in English (both written and verbal). Strong technical writing skills with attention to detail and verbal/written communication skills preferred.

Physical Requirements:

  • Traditional office environment, with frequent walking to other areas of the facility, including production areas, loading docks, mechanical spaces and warehouse

Job Type: Contract

Salary: $70,000.00 to $80,000.00 /year

Experience:

  • Validation: 4 years

Education:

  • Bachelor's

Location:

  • Jersey, GA

Required work authorization:

  • United States