Lead CQV Engineer

3 weeks ago


Newbury Park, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Develop the Commissioning and Qualification Plans for assigned projects.
  • Participate in risk assessments and design qualifications as needed.
  • Develop and /or update requirement traceability matrices as needed for both design traceability and testing traceability.
  • Oversee and manage deliverables from vendors performing commissioning and qualification deliverables.
  • Develop and execute commissioning and qualification protocols, as needed.
  • Review and Approve commissioning and qualification protocols develop and executed by others.
  • This includes both pre-execution review and approvals, as well as post-execution review and approvals.
  • Investigate test failures, provide the corrective actions and ensure all necessary retesting is completed to close out the test failures and associated protocols.
  • Provide status updates to project leadership on schedules, resource loading and cost.
  • ctively collaborate with multiple groups (system owners, quality, automation, project management) to identify and resolve issues as early as possible.
  • uthoring, editing, and executing technical commissioning, qualification and validation documentation for standard equipment/systems/ software, and processes as part of team as directed by the project leader.
  • Running test scripts and documenting results.
  • dherence with project schedule for all assigned activities.
  • Maintaining clear, detailed records qualification and validation.
  • Documenting impact and risk assessments as part of a team.
  • Completing user interface testing, software verification, and complete alarm testing on automated systems.
  • Developing, reviewing, and executing testing documentation.
  • Making recommendations for design or process modification based on test results when executing test scripts.
  • General understanding of capital equipment implementation and process knowledge.
  • Understanding validation documents, URS, IQ, OQ, PQ.
Requirement:
  • Must be willing to work onsite in Thousand Oaks, CA.
  • Bachelor's Degree or equivalent required.
  • Demonstrated experience in leading CQV activities specific to Process Equipment.
  • Proficiency using PC and Microsoft Office tools.
  • Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
  • bility to work as part of a team.
  • Strong problem-solving and critical thinking skills.
  • Excellent organizational and time management skills.
  • Strong attention to detail.
  • GMP and Good Documentation Practice.
  • Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
  • Basic skills with EXCEL and PowerPoint.
  • Strong interpersonal skills and clear communication capabilities.
  • Experience with and tolerance for high levels of challenge and change.
  • Demonstrated capability to deliver on the Senior Project Engineer responsibilities.
  • bility to mentor and guide less experienced team members.
  • bility to communicate effectively with clients.
  • Proven ability to identify areas of business expansion and report to management team for follow-up.
  • bility to lead risk assessment activities to determine project goals for Verista products.
  • Experience in vision inspection and automation manufacturing environments with demonstrated ability to generate project engineering deliverables independently.
  • bility to work independently and as part of a team, with the ability to transition between the two.
  • Demonstrated capability to deliver on the Project Engineer Responsibilities.
  • Experience in vision inspection and automation manufacturing environments with the ability to generate project engineering deliverables with support of mentor.


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