Various Validation Engineer Positions, AGC Biologics In Boulder, CO

Company: AGC Biologics, 5550 Airport Blvd, Boulder, CO 

  • Leading global Contract Development and Manufacturing Organization (CDMO), 
  • Providing world-class development and manufacture of mammalian and microbial-based therapeutic proteins, plasmid DNA (pDNA), viral vectors and genetically engineered cells

Hiring these Validation Engineer position are recruited through Aerotek

  • Person: Lauren Delgesso, Recruiter, Engineering & Sciences
  • office: 720.773.3965 mobile: 720.441.3592 
  • e-mail: ldelgesso@aerotek.com with Subject "Job: AGC Biologics, Validation Engineer"

Title: Validation Engineer II, CTU Mapping

Summary:
  • Qualification of new equipment, controlled temperature unit mapping and the maintenance of a validated state for existing equipment
  • Determine test scripts and acceptance criteria according to system URS requirements.
  • Generate qualification protocols (IQ, OQ, PQ) and summary reports
  • Knowledge of system validation "life-cycle" concept
  • Investigate, resolve and close deviations and associated CAPAs.
  • Bachelor’s degree in Life Sciences, Engineering, or related discipline with 2+ years of experience.

Title: Validation Engineer II, CTU Mapping

Summary:
  • Qualification of new equipment, controlled temperature unit mapping and the maintenance of a validated state for existing equipment
  • Determine test scripts and acceptance criteria according to system URS requirements.
  • Investigate, resolve and close deviations and associated CAPAs.
  • Generate qualification protocols (IQ, OQ, PQ) and summary reports
  • Knowledge of system validation "life-cycle" concept
  • Bachelor’s degree in Life Sciences, Engineering, or related discipline with 2+ years of experience.

Title: Validation Engineer II/III - Facilities, Utilities, Equipment

Summary:
  • Qualification and validation of facilities, utilities and production equipment maintaining the qualified state throughout the system lifecycle
  • Develops test scripts and acceptance criteria relative to system URS requirements.
  • Investigate, resolve and close deviations and associated CAPAs.
  • Generate qualification protocols (IQ, OQ, PQ) and summary reports
  • Knowledge of system validation "life-cycle" concept
  • Bachelor’s degree in Life Sciences, Engineering, or related discipline with 2+ years of experience.

Title: Validation Engineer II/III, Computer Systems Validation

Summary:
  • Qualification of computerized cGMP systems, new equipment, and the maintenance of a validated state for existing systems and equipment
  • Follows provided URS documents to determine test scripts and acceptance criteria.
  • Investigate, resolve and close deviations and associated CAPAs.
  • Performs validation of computerized systems following GAMP 5 guidance.
  • Investigate, resolve and close deviations and associated CAPAs.
  • Generate qualification protocols (IQ, OQ, PQ) and summary reports
  • Knowledge of system validation "life-cycle" concept
  • Bachelor’s degree in Life Sciences, Engineering, or related discipline with 2+ years of experience.

Title: Validation Engineer II/III, CV-SIP

Summary:
  • Qualification of upstream cell culture and downstream purification systems and equipment, new equipment, and maintaining the validated state
  • Performs qualification of facilities, clean utilities, manufacturing and analytical equipment to demonstrate that the equipment is fit for its intended use.
  • Investigate, resolve and close deviations and associated CAPAs.
  • Generate qualification protocols (IQ, OQ, PQ) and summary reports
  • Knowledge of system validation "life-cycle" concept
  • Bachelor’s degree in Life Sciences, Engineering, or related discipline with 5+ years of experience.

Title: Validation Engineer III/IV (Lead), CV-SIP

Summary:
  • Cleaning validation and cleaning monitoring program
  • Performs cleaning validation activities associated with the generation of validation master plans, protocols and reports
  • Participates in the development of cleaning cycles and procedures.
  • Generate qualification protocols (IQ, OQ, PQ) and summary reports
  • Knowledge of system validation "life-cycle" concept
  • Bachelor’s degree in Life Sciences, Engineering, or related discipline with 5+ years of experience.

Title: Validation Engineer III/IV, Downstream/Upstream

Summary:
  • Ownership of production systems validation and be responsible for execution of the validation master plan
  • Authors, reviews and executes validation protocols in conjunction with engineering, manufacturing and QA personnel.
  • Apply validation/engineering concepts and company procedures to generate validation protocols and reports
  • Generate qualification protocols (IQ, OQ, PQ) and summary reports
  • Knowledge of system validation "life-cycle" concept
  • Bachelor’s degree in Life Sciences, Engineering, or related discipline with 5+ years of experience.

For More Information and Apply See Job link above or Contact recruiting firm AeroTek via

  • Person: Lauren Delgesso, Recruiter, Engineering & Sciences
  • office: 720.773.3965 mobile: 720.441.3592 
  • e-mail: ldelgesso@aerotek.com with Subject "Job: AGC Biologics, Validation Engineer"
Posted by Arnold Miller on Oct 15, 2020 7:56 AM America/Chicago

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