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Validation Engineer

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Date: Aug 4, 2022

Location: Bethlehem, PA, US, 18017

Company: Lubrizol Corporation

87481 

The Lubrizol Corporation, a Berkshire Hathaway company, is a market-driven global company serving customers in more than 100 countries. We own and operate manufacturing facilities in 17 countries, as well as sales and technical offices around the world. Through our global sales and manufacturing networks, we are able to deliver the products and services our customers need, where and when they need them.

 

Operating under the general guidance of the Manager of Validation, the Validation Engineer, provides technical support for the qualification of equipment, utilities and systems that support GMP Manufacturing activities within the Bethlehem facility.  The Validation Engineer has responsibility for supporting the validation and qualification efforts to implement new and existing equipment and systems as well as the performance of routine re-validations.  They are accountable for producing top-notch, accurate, and high quality documentation that will meet or exceed industry standards.

 

Duties & Responsibilities:

 

  • Prepare and execute installation qualification (IQ), operational qualification (OQ), performance qualification (PQ) and process qualification (PRQ) protocols for equipment, systems and processes.
  • Prepare qualification summary reports (QSR) and validation summary reports (VSR).
  • Prepare and/or review user requirements specifications and data sheets for the purchase of new equipment and systems.
  • Prepare and execute design qualification (DQ) and traceability matrix (TM) documents.
  • Review and comment on vendor supplied equipment documentation such as (FRS, DDS, GA drawings, P&ID, etc.).
  • Prepare and execute Factory/Site Acceptance Tests (FAT or SAT) for equipment.
  • Prepare and/or review Standard Operating Procedures for equipment and systems.

 

 

Skills, Experience, and Qualifications:

  • Bachelor of Science in a related field or equivalent education/training/experience.
  • 5+ years related experience in the pharmaceutical industry with direct experience with equipment qualification and validation.
  • Thorough knowledge and training in writing and execution of quality documentation such as IQ/OQ/PQ, SOP, etc.
  • Thorough knowledge of cleaning and sterilization validations including CIP, SIP, autoclave, VHP, etc.
  • Knowledge and familiarity of various process equipment used in the pharmaceutical industry such as autoclaves, fillers, lyophilizers, pumps, vessels, mixers, etc.
  • Thorough knowledge of GLP/GMP requirements as they pertain to documentation, equipment, systems and processes used in GMP manufacturing operations along with understanding of 21CFRPart11.
  • Thorough knowledge and ability to read and understand technical documentation such as mechanical drawings, P&I drawings, specifications, data sheets, etc.
  • Knowledge and ability to use test instruments such as multimeters, tachometers, ammeters, pH meters, data loggers, etc. used during the validation process.
  • Basic knowledge of PLC software such as RSLogix desirable.
  • Understanding of Biological Indicators, Temperature Mapping, Aseptic Techniques, EM and Smoke studies.
  • Good interpersonal skills; displays professionalism
  • Ability to work in a team environment, but also work independently; honest and trustworthy
  • High energy, quick learner, positive attitude

 

Working Conditions:

  • Must be willing/able to work in a plant environment
  • Work may occur around chemicals, nuisance odors, and noise from operating areas
  • Ability to lift/carry/move up to 30 pounds
  • May require standing for extended periods of time
  • Expected to wear all required PPE
  • Safely work independently and around others by following all required procedures

 

Why Lubrizol?

 

  • Competitive salary with performance-based bonus plans
  • 401K Match PLUS Age-weighted defined contribution plan
  • Competitive medical, dental & vision offerings
  • Health Savings Account
  • Paid Holidays, Vacation, Parental Leave

 

 

While headquartered in the United States, Lubrizol is truly a global specialty chemical company.  We have a major presence in five global regions and do business in more than 100 countries. Our corporate culture ensures that Lubrizol is one company throughout the world, but you will find each region is a unique place to work, live and play.

 

Lubrizol is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to sex, race, color, national origin, citizenship, age, religion, marital status, military service, sexual orientation, genetic information, gender identity, or any other characteristic or trait protected by federal, state, or local law.

 

 

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