Quality Validation Engineer

  • Poly-Med, Inc.
  • Anderson, SC, USA
  • Jun 22, 2020
Full time Manufacturing Pharmaceutical Research

Job Description

Description:

This position is self-directed and is responsible for performing product, process and equipment validations/qualification and other quality related activities with minimal guidance and supervision. Has broad knowledge of commonly used concepts, practices, and procedures within validation and quality assurance field. Relies on personal experience and judgment to perform primary job responsibilities.

Responsibilities:

  • Primarily responsible to participate in development, performance, review and approval process of test method, instrumentation, and equipment validation/qualifications.
  • May lead validation projects as required.
  • Participate in review of product and process changes for effect on existing validations, recommend and perform re-validations as required.
  • Assist in defining, developing, maintaining, and supporting various quality programs along with their performance measurements and reporting requirements
  • Basic knowledge of change control and risk-management and risk analysis activities
  • Represent Quality/Validation needs on multi-functional design teams and Project/Program Core Teams
  • Work closely with Manufacturing to identify and resolve production deficiencies related to validation

Required Knowledge, Skills and Abilities

  • 3+ years hands on equipment qualification and test method validation experience in GMP regulated environment (preferably pharmaceutical)
  • Skilled with Microsoft Office Software (Microsoft Word, Excel, et. al.)
  • Good knowledge of statistics and Mini-tab software
  • Good work organizational skills
  • Ability to manage time and prioritize
  • Excellent communication and interpersonal skills
  • Ability to assertively interact with people at all levels of the organization
  • Good technical writing skills, grammar
  • Ability to handle highly confidential business information
  • Strong attention to detail
  • Ability to think proactively, troubleshoot, investigate and improve systems
  • Highly responsible for actions of self and possibly others on the team

Education/Experience Requirements:

Required- Bachelor’s Degree (preferably in Chemistry, Polymer Science or Mechanical Engineering) and 2+ years of Pharmaceutical industry experience

Preferred – Prior validation experience is preferred.

Physical Requirements for Quality Validation Engineer:

Requires walking, ability to climb stairs, stoop, kneel, and reach above shoulder heights and below waist throughout the day. Lifting as required with proper lifting techniques up to 50 pounds on occasion. Specific vision abilities required.

Working Conditions for Quality Validation Engineer:

This position is in a production environment where the use of personal protective equipment such as hearing protection, safety glasses, and safety shoes are mandated. The employee is frequently exposed to moving mechanical parts; some exposure to changes in temperature, noise, dust, and chemicals.

Poly-Med Employees are eligible for multiple benefits including vacation, choice in health benefits and optional plans. Poly-Med, Inc. is on a once a month payday schedule.

Poly-Med, Inc. provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, disability, genetic information, marital status, amnesty, or status as a covered veteran in accordance with applicable federal, state and local laws. Poly-Med, Inc. is an equal opportunity employer of individuals with disabilities and supports the hiring of veterans.