WuXi AppTec

Equipment Validation Specialist

Job Locations US-GA-Marietta, Georgia
Job ID
2021-8814

Overview

WuXi AppTec is a leading global pharmaceutical, medical device open-access capability and technology platform company with global operations. We have an opening for an Equipment Validation Specialist.

Responsibilities

Manages equipment validation and qualification processes. Will coordinate with equipment vendors in establishing IOPQ documents. Will assist in equipment maintenance and calibration and environmental monitoring activities. Identifies and recommends improvements to facility performance by working with site management team to assure regulatory compliance and consistency with the company’s policies and procedures. Will identify and propose remediation for existing and potential validation issues; provide technical expertise and provide solutions to maintain compliance.

Qualifications

Essential Job Functions:

  • Write, develop and enact IOPQ’s and SOP’s for various biotechnology equipment.
  • Lead the development of gap qualification protocols.
  • Strong project management skills. Ability to lead and direct a cross functional team to ensure timely equipment installation and validation.
  • Evaluate, analyze, and recommend purchases of inspection, measuring, and test equipment used in laboratory testing and manufacturing processes.
  • Evaluate validation impact assessment regarding change control, in collaboration with change request owners.
  • Perform risk assessment as part of the overall validation process.
  • Assemble, evaluate, and report group metrics measuring compliance and quality key performance indicators.
  • Normally receives minimal instructions on routine work and detailed instructions on new assignments.
  • Contributes to the overall operation and to the achievement of departmental goals.
  • Perform job specific tasks in compliance with applicable Regulations, International Standards, and WuXi AppTec Policies and Standard Operating Procedures.
  • Work under supervision from senior personnel.
  • May be required to assist in other departments.
  • Other duties as assigned.

Experience / Education

  • 3 to 5+ years in a similar role in a FDA regulated facility with hands on validation experience (Experience writing and performing IOPQ validations for pharma, biotech or the life sciences).

Knowledge / Skills / Abilities:

  • Writing, reviewing and enacting IOPQ protocols and SOP’s.
  • Ability to evaluate the requirements for equipment regarding categorization, calibration, qualification/validation based on applicable standards and regulations.
  • Analytical thinking skills.
  • Thorough understanding of good manufacturing principles.
  • Proficient in Oral & Written communication skills.
  • Need to be able to read, write and understand English.
  • Proficient in Microsoft (Excel, Word, Outlook, PowerPoint).
  • Ability to work in a team environment and independently as required

Physical Requirements:

  • Perform primary sedentary work
  • Must be able to work in an office environment with minimal noise conditions.
  • Must be able to wear appropriate PPE
  • Ability to stand / sit / walk for long periods of time
  • Ability to lift 10 lbs routinely
  • Ability to crouch, bend, twist, and reach
  • Must be able to perform activities with repetitive motions

 

Equal Opportunity Employer Minorities/Women/Veterans/Disabled

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