Commissioning, Qualification & Validation Engineer III / Senior – JPOD Expansion

at Just - Evotec Biologics
Location Redmond, Washington
Date Posted June 22, 2022
Category Engineering
Job Type Not Specified

Description

Just is seeking a highly motivated Commissioning, Qualification and Validation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this role is to support CQV activities including manufacturing equipment, systems, facilities, and utilities across global expansion sites. These responsibilities span all phases of the validation lifecycle from system implementation, system qualification, system support and maintenance, to system retirement. The successful candidate must be willing to travel to support Just-Evotec Biologics facility start up project located in Toulouse, France.

Roles Primary Responsibilities:

  • Support the generation of key deliverables including system impact assessments, criticality assessments, risk assessments, user requirements specifications, function specifications, and design specifications
  • Provide CQV vendor/contractor oversight and direction including resource and budget management
  • Lead in the generation, execution, review, and approval of commissioning and qualification protocols for manufacturing equipment, systems, facilities, and utilities
  • Lead in the generation and execution of requirements traceability matrices and qualification summary reports
  • Validation deviation resolution including troubleshooting and root cause analysis
  • Periodic review and requalification of qualified equipment, systems, and utilities to ensure system remains suitable for its intended use and to verify compliance with appropriate industry regulations and company policies
  • Support the development of the qualification and validation programs at Just
  • Develop phase appropriate ways to comply with regulatory requirements
  • Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings

Position Requirements:

  • Bachelor's degree in engineering science or related program with 5+ years of relevant experience
  • Understanding of industry standards and best practices for a science and risk-based approach to qualification of systems, equipment, utilities, and facilities
  • Working knowledge of US FDA CFRs and European EMA, including ICH regulations
  • Experience with quality risk management
  • Experience with sampling techniques and cleaning cycle development
  • Ability to perform New Product Introduction (NPI) assessments in support of cleaning validation for commercial readiness
  • Experience authoring, reviewing, and approving validation documentation
  • Knowledge of process equipment, utilities, operations, and engineering principles
  • Must possess strong focus on quality and attention to detail
  • Must possess problem-solving and critical thinking skills
  • Motivated, self-starter with strong mechanical aptitude
  • Ability to work both independently and collaboratively across multiple disciplines in a fast-paced and dynamic environment
  • Possess effective task/time management organizational skills

Additional Preferred Qualifications:

  • Strong understanding of process automation (e.g. DeltaV)
  • Previous work experience with Distributed Control System (DCS), Building Automation Systems (BAS), PLC, SCADA, PI, and MES will be a plus
  • Applies knowledge and expertise to solve complex technical problems
  • Significant contributor to multi-disciplinary teams at the functional level
  • Working knowledge of Computer Systems Validation
  • Working knowledge of Quality Control equipment and systems
  • Experience performing swab and rinse sample collection
  • Experience with soils analysis, detergent analysis, and MACO (Maximum Allowable Carry Over) calculations.
  • Verbal and written communications skills in both English and French

Worker

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