Commissioning, Qualification & Validation Engineer I/II - Manufacturing Technical Operations

Location
Redmond, WA, United States
Posted
Sep 23, 2020
Ref
624485478
Hotbed
BioForest
Required Education
Bachelors Degree
Position Type
Full time
Just is seeking a highly motivated Commissioning, Qualification & Validation Engineer that desires a significant opportunity to improve worldwide access to biotherapeutics. The primary focus of this job is to lead the process equipment and utilities commissioning, qualification and validation activities required for late-stage clinical and commercial biologics manufacturing. This comprises all phases of implementation, including ownership of key deliverables such as risk assessments, user requirements specifications, functional and design specifications. The selected candidate will also be responsible for commissioning and qualification protocol generation and execution as well as validation summary reports. Additional job responsibilities will include periodic review and requalification of validated equipment and systems to verify compliance with appropriate regulations and maintaining required change control procedures and impact assessments.

Position Requirements:
  • Bachelor's degree in engineering science or related program with 1+ years relevant experience
  • Understanding of industry standards and best practices for equipment and utilities validation
  • Working knowledge of US FDA CFRs and European EMA, including ICH regulations
  • Experience with quality risk management and risk-based validation approaches
  • Experience on commissioning and qualification projects employing proven engineering and project management skills
  • Knowledge of process equipment and utilities, operations, and engineering principles
  • Candidate must possess strong focus on quality and attention to detail
  • Motivated, self-starter with strong mechanical aptitude
  • Good interpersonal, team, and communication skills are a must
  • Excellent oral and written communication skills

Additional Preferred Qualifications:
  • Previous work experience with Distributed Control System (DCS), Building Automation Systems (BAS), PLC, SCADA, PI, and MES will be a plus
  • Strong understanding of process automation (e.g. DeltaV)
  • 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

About Just - Evotec Biologics

Just - Evotec Biologics, wholly-owned by Evotec SE, 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. Just's focus is to create access and value for a global market through scientific and technological innovation. Our state-of-the-art labs and cGMP clinical manufacturing plant are co-located in Seattle's South Lake Union neighborhood - the center of Seattle's medical, global health, and technology industries and a noted top emerging life science hub in the U.S. Our fast-growing team of 100 employees is expanding Just's innovative platform and footprint - building our first North American J.POD® commercial manufacturing facility in the Seattle area. For job opportunities, learn more at www.just.bio/careers