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Senior Compliance Engineer

Company: PQE Group
Location: Seattle
Posted on: January 15, 2022

Job Description:

PQE is a service provider company, leader in the Pharmaceutical and Medical Device sectors since 1998. With a network of more than 900 consultants, PQE delivers the highest level of expertise to Life Science customers worldwide and has successfully completed 12,000+ projects for 1,400+ clients. An international group, PQE operates in over forty countries throughout Europe, Asia, and the Americas. PQE offers worldwide coverage with offices and representatives across Europe, North America, Asia, the Middle East, and Latin America, in order to better serve these specific local markets. Further information can be found at www.pqegroup.com.
Due to constant growth, PQE is looking for a new Senior Compliance Engineer. This will initially be a 12 month contract assignment that will be worked partially on site near Portland, OR or Bothell, WA.
Responsibilities

  • Work on a cross-functional team consisting of facilities, manufacturing, QC, GLP and QA preparing a biotech manufacturing plant for a commercial pre-approval inspection (PAI) by the FDA
  • Complete validation remediation of facilities, lab equipment, manufacturing equipment, materials management equipment and utilities including data integrity remediation within GMP quality management guidelines
  • Will be given responsibility for discreet tasks and projects that will often involve coordinating a cross-functional team
  • Escalate issues to management when they require solutions outside of current processes or pose significant compliance or business risk
  • Write CAPA plans to address gap assessment findings in collaboration with cross-functional team
  • Collaborate with validation engineers to document completed CAPA action items
  • Author and coordinate change control documentation
  • Author and revise standard operating procedures
  • Support primary audit team as a Subject Matter Expert (SME) on the validation remediation aspects of the project
  • Complete all work in compliance with pharmaceutical data integrity requirements
    Requirements
    • At least 7 years of experience leading deviation investigations, CAPA process, participating in audits, and responding to audit observations
    • Bachelors in engineering, science, or equivalent working experience
    • Must have previous experience working in a regulated biotech, pharmaceutical or health care organization
    • Demonstrated ability to effectively support large projects in a GMP and/or GLP environment, preferably with the role of facilities qualification and/or engineering
    • Ability to work independently with minimal managerial oversight
    • Working knowledge of industry regulations, standards and baselines from FDA, international pharmaceutical regulations, ISPE, or any other relevant regulatory agency
    • Hands on experience with audit preparation and readiness with quality, compliance and safety
    • Proven track record of applying GMP industry regulation requirements and engineering best practices to an international life sciences company
    • Ability to manage priorities, deliverables, and schedule milestones

Keywords: PQE Group, Seattle , Senior Compliance Engineer, Engineering , Seattle, Washington

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