Validation Specialist

Highly Competitive Salary
  1. Permanent
  2. Laboratory Technician, Pharmacokineticists, Pharmacology
  3. United States
Memphis, USA
Posting date: 21 Aug 2020

Proclinical is currently recruiting for a Validation Specialist with a pharmaceutical company located in Memphis, TN.

Job Responsibilities:

  • Responsible for helping to maintain the validation program including manufacturing, packaging, facilities, utilities, equipment, control systems, and processes at the Memphis facility. will generate validation documentation and plan validation projects.
  • Effectively resolve issues associated with validation efforts and represent that department during internal audits.
  • Responsible for the periodic trending of process capability data to ensure compliance with FDA standards.
  • Develop, implement, and maintain a continuous verification program to include periodic trending of process capability data including all necessary procedures.
  • Write and execute IQ, OQ, and PQ protocols and summary reports for the facilities/utilities, manufacturing, and packaging areas as needed.
  • Write and execute PV protocols and summary reports for product reformulations and New Product Introductions (NPIs).
  • Participates in Validation SOP development and the ongoing maintenance of the validated status of GXP systems.
  • Responsible for driving all aspects of the Validation Life Cycle in Packaging and Utilities/Facilities from design through operation and improvement.
  • Monitors validation criteria and assures compliance with written validation standards.
  • Maintain up to date knowledge of validation requirements, practices, and procedures and instruct other members of the validation working party.
  • Leads and ensures accountability to the site's Product Lifecycle Management governance process.
  • Support site during internal audits as required.
  • Comply with all local, state and federal EHS laws and regulations, and all Global EHS requirements.

Skills and Requirements:

  • Bachelor of Science or Bachelor of Engineering
  • Basic understanding of scientific or engineering discipline, validation or statistics
  • 3-5 years of validation experience in pharmaceutical or consumer healthcare industry
  • Successful demonstration of validation experience within a pharmaceutical or consumer healthcare manufacturing environment designated as new product introduction site with new products, processes, and equipment are being introduced continuously.
  • Effective Strategic Communication skills -delivering written and oral communication with clarity and impact, tailored to the audience.
  • Strategic Customer Focus- taking initiative (a clearly interconnected set of activities) designed to raise the 'value added' for to ensure a wider or long term effect/benefit.

If you are having difficulty in applying or if you have any questions, please contact Sarah Beshara at 267-477-3355.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.