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Company Overview 

Yoh, a Division of Day & Zimmermann, delivers talent and workforce solutions in Aerospace & Defense, Engineering, Information Technology, Life Sciences and Telecommunications, helping clients address complexities of managing cost, risk, quality and value of the entire workforce. Founded in 1940, Yoh is headquartered in Philadelphia, PA and operates from 75 locations.

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Validation Engineer

Job Description 

Yoh Scientific has a contract to hire opening for a Validation Engineer to join our customer in Durham, NC.

 

Job Duties:

 

  • Write and Execute Validations/Re-Validations to ensure applicable equipment and systems are maintained in a compliant state.
  • Perform Gap Analysis on existing validations and processes to determine if they are in a compliant state.
  • Troubleshoot existing process equipment, utilities, and systems as technical engineer/system expert as problems arise.
  • Serve as Project Engineer/Manager for new incoming utility, equipment, and systems. Responsibilities include preparation of User Requirement Specifications (URS), including bid procurement, bid analysis, project scheduling, and validation scheduling.
  • Use knowledge and experience to write, perform, and summarize qualification activities to support regulatory compliance. This responsibility may include the incumbent to lead multi-departmental project teams in addressing regulatory obligations.
  • Write and/or revise departmental standard operation procedures
  • Proactively prepares and communicates validation project status reports for management review identifying areas of concern with proposed corrective actions.
  • Uses knowledge and experience to ensure that validation project designs are safe, efficient, and incorporate best engineering and compliance practices.
  • Maintain Engineering and Validation history files for equipment and systems.
  • Assist in the maintenance of documentation related to the Manual Inventory System and Calibration Management System.
  • Assist in the Change Control management of GMP system such as the Building Management System.
  • Follow directives from supervisors/managers in an appropriate manner.
  • Adhere to Company policies regarding attendance and personal development.
  • Perform other tasks as requested by management.
 


Job Requirements 

  • Bachelor’s degree in Engineering, Chemical or Life Science preferred. Pertinent experience that results in knowledge and skills to perform the position responsibilities will be considered.
  • A minimum of four (4) years relevant validation experience in the pharmaceutical, medical diagnostics or food industry; other related experience may be considered.
  • Ability to effectively and efficiently manage a demanding validation and project management workload including normal workplace stress and/or pressures
  • A strong familiarity with cleaning, sterilization, sanitary design, and aseptic operations is required.
  • Prior experience in aseptic manufacturing and laboratory testing assay qualifications will be highly weighted.
  • The individual should have strong technical skills, demonstrated leadership, teamwork skills, be self directed, and exhibit strong oral and written communication skills.
  • Proven knowledge and experience with the qualification of multiple GMP systems (i.e., utilities, production equipment, lab instruments, computer systems), and the validation of sterilization and cleaning processes.
  • In depth knowledge of GMP, QA/QC principles, regulatory compliance, and validated SCADA/PLC systems.
  • Strong deviation investigation, corrective action implementation, and resolution skills in support of validation studies

 

Discover all that's possible with Yoh Scientific. Apply now.

 

 

Partnering with Yoh

In addition to great career opportunities, consulting with Yoh comes with its perks:

  • Competitive compensation plans
  • Wide variety of benefit options
  • Yoh Advantage - our consultant rewards program that offers discounts and perks at leading companies and with national brands exclusively for Yoh