Sr. Validation Engineer – Seattle, WA

Job Type: Full-time
Schedule: 40-hour work week, Monday through Friday
Office Location: Bothell, WA.
Salary: Commensurate with experience. Target salary range $90K-$130K annually.

Job Description

RPA Engineering is currently recruiting a Sr. Validation Engineer, to support and grow the Bothell, WA office. The successful candidate will lead commissioning, qualification, and validation (CQV) projects, focusing on cGMP production of biologics and advanced therapies for our clients in the Seattle, WA and Pacific Northwest areas.

Education & Experience

Required

  • BS Engineering or other related technical discipline.
  • Pharmaceutical or biologic industry experience.
  • 10+ years of experience in cGMP validation.
  • Create and maintain commissioning, qualification, and validation (CQV) protocol and report templates.
  • Experience leading a team executing the CQV activities across multiple projects.

Preferred

  • Continuing education in pharmaceutical technology and/or cGMP.

Tasks, Responsibilities, and Utilized Skills

  • Excellent interpersonal and communication skills, both verbal and written, are required. Special emphasis on technical writing, requiring no edits.
  • Successfully planning, tracking, and executing validation projects with respect to scope, quality, schedule, and cost.
  • Ability to manage multiple conflicting priorities required.
  • Superior engineering aptitude required. Demonstrated ability to cross the validation disciplines (i.e. equipment, automation, manufacturing, packaging, cleaning) with subject matter expertise.
  • Self-starting leader.
  • Quantify resource requirements in area of responsibility for purposes of capital appropriation.
  • Build culture of proactive quality.
  • Perform field/site activities including, but not limited to, the following:
    • Attend and witness FATs and SATs as a representative of IPS clients
    • Execution of commissioning forms and witnessing vendor start-up and testing
    • Walkdown and verification of system drawings (P&IDs, as-builts, etc.)
    • Compile data and prepare reports for completed C/Q/V activities including ETOPs, protocol data packages, etc.
    • Assist in deviation investigation and resolution of problems and issues encountered during field execution activities
    • Work with the Project Delivery department or CM for start-up and vendor testing, witness and troubleshoot as required.

 Company Benefits

  • Excellent work-life balance and flexible work schedule
  • Hybrid work environment, ability to work from home part-time
  • Growth opportunities within the organization
  • Paid time off, sick time, and overtime
  • Parental leave
  • 401(k) matching
  • Insurance plans (health, dental, vision, life, etc.)

RPA Engineering is a professional engineering consulting firm offering comprehensive mechanical, electrical and process engineering, machine design, structural analysis services, project management, and CQV. Operating for more than 30 years, RPA provides high quality, cost-effective engineering and design services from its multiple locations; and onsite corporate services.

 RPA Engineering was named in 2010 to the Inc. 5000 list of fastest growing U.S. based entrepreneurial companies. As part of the list, RPA Engineering was named as one of the top 100 Engineering firms in the country.

 RPA Engineering is an equal opportunity, affirmative action employer of protected veterans (M/F/D/V).

Attention Search Firms / Third Party Recruiters: RPA Engineering is not seeking assistance or accepting unsolicited resumes from search firms for employment opportunities with RPA Engineering. Regardless of past practice, all resumes submitted by search firms to any employee at RPA Engineering via e-mail, the Internet or directly to hiring managers at RPA Engineering in any form without a valid written search agreement in place for a specific position will be deemed the sole property of RPA Engineering, and no fee will be paid in the event a candidate is hired by RPA Engineering as a result of the referral or through other means.

 

Posting #: 24-004

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