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Commissioning, Qualification & Validation Engineer III / Senior – Manufacturing Technical

Employer
Just - Evotec Biologics
Location
Redmond, WA
Start date
Sep 10, 2022

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Job Details

Just is seeking a highly motivated Commissioning, Qualification and Validation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. One of the focuses of this job is to build and lead a cleaning validation program across multiple drug substance biologics manufacturing facilities. Additionally, the engineer will also support various commissioning, qualification, and validation (CQV) activities for manufacturing equipment, systems, facilities, and utilities. These responsibilities span all phases of the validation lifecycle from system implementation, system qualification, system support and maintenance, to system retirement.

Roles Primary Responsibilities:

  • Develop a phase appropriate approach to cleaning validation within the Just-Evotec Biologics Manufacturing facilities to meet regulatory and client requirements while ensuring a risk-based approach is followed.
  • Implement cleaning requirements for New Product Introduction (NPI) efforts.
  • Supporting the generation of key deliverables (in a phase appropriate compliance manner) including system impact assessments, criticality assessments, risk assessments, user requirements specifications, function specifications, and design specifications
  • 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
  • Supporting the development of the qualification and validation programs at Just
  • Develop compliant and novel ways to comply with regulatory requirements
  • Develop sitewide cleaning validation program
  • Support inspection readiness activities, Health Authority and Client audits, and support corrective actions based on audit findings
  • Supporting CQV activities at the Seattle site (early stage clinical)
  • Supporting CQV activities across global expansion sites

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
  • Excellent interpersonal, team, and communication skills are a must
  • High level oral and written communication skills are a must
  • 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.


Worker

Company

Just - Evotec Biologics, is a unique platform company that integrates the design, engineering, development, and manufacture of biologics. With deep experience in the fields of protein, process and manufacturing sciences, the Just team came together to solve the scientific and technical hurdles that block access to life-changing protein therapeutics; from the design of therapeutic molecules to the design of the manufacturing plants used to produce them. Our focus is to create access and value for a global market through scientific and technological innovation.  Learn more at www.just.bio.

Find Us
Phone
206-651-5094
Location
401 Terry Avenue North
Seattle
98109
US
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