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Validation Engineer III

4 months ago

Greenville, United States Thermo Fisher Scientific Full time
Work Schedule
Other

Environmental Conditions
Office

Job Description

Business information

The Greenville, North Carolina, USA site is a large, multipurpose pharmaceutical development, manufacturing, and packaging campus. The operation provides both development and commercial services for sterile injectables and oral solid dose forms.

Position summary

Provides direct quality support (e.g. compliance, regulatory assessment, and validation) to the business unit, clients and corporate management through the leading and completing tasks associated with key quality functions. Supervises and/or leads lower level staff as assigned. Performs quality functions to ensure accurate and on time completion with frequent decision making, coordination and communications required. Creates, reviews, approves, tracks and presents documents and procedures required for compliance with pharmaceutical regulations. Identifies areas of non-compliance, review recommendations of others and implement solutions to resolve major quality and productivity issues. Implements systems to ensure compliance with new and changed regulations. Performs activities across key quality functions to support the business units. Prepares and conducts quality systems training across the company.
Key Responsibilities:
  • Manages, leads, schedules, executes and supervises multiple projects of high complexity with multi-disciplinary departments to ensure on time completion of deliverables.
  • Serves as principle/validation liaison for negotiating with clients on agreements/projects and resolution of significant validation, product and regulatory issues. Coordinates, reviews and prepares customer audit responses and reports.
  • Prepares, reviews and approves production, validation, audit reports and/or master batch record documents, procedures, and rationales.
  • Evaluates new regulations, changes to existing regulations and regulatory trends; performs gap analysis to determine deficiencies and take appropriate actions.
  • Establishes actions and implements systems to achieve process improvements and efficiencies to address shortcomings in processes and systems.
  • Serves as principle in hosting and coordinating regulatory inspections performed by the FDA, MCA and other regulatory agencies.
  • Defends policies, procedures, rationales and methods in the area(s) of expertise during regulatory and client audits.
  • Establishes and supervises quality programs and plans (e.g. validation, QAT, supplier certification).
Qualifications:
  • Minimum education Required: Associate's degree
  • Bachelor's degree in Engineering or Biological science related field is preferred.
  • Four (4) years of relevant work experience in the pharmaceutical or a regulated industry required
  • Two (2) years of validation experience, is required.
  • Ability to work in a fast paced environment under pressure and able to multi-task.
  • Effective time management and prioritization skills
  • Very high degree of interpersonal skills to establish and maintain effective working relationships with employees and the public, including tact to handle sensitive matters. Highly effective verbal and written communication skills.