Lead CQV Engineer / Lead Validation Engineer - Katalyst Healthcares & Life Sciences
Thousand Oaks, CA 91319
About the Job
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.
- Actively collaborate with multiple groups (system owners, quality, automation, project management) to identify and resolve issues as early as possible.
- Authoring, 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.
- Adherence 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.
- 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.
- Ability 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.
- Ability to mentor and guide less experienced team members.
- Ability to communicate effectively with clients.
- Proven ability to identify areas of business expansion and report to management team for follow-up.
- Ability 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.
- Ability 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.
Source : Katalyst Healthcares & Life Sciences
