Senior Validation Engineer Position Available In Duval, Florida

Tallo's Job Summary: The Senior Validation Engineer is responsible for designing validation plans, conducting engineering studies, and maintaining detailed records for compliance audits. Requirements include a Bachelor's Degree, on-site work in Kalamazoo, MI, and strong communication skills. Proficiency in Microsoft Office tools, GMP, and Good Documentation Practice is essential. This position requires experience in leading CQV activities and a high tolerance for challenge and change.

Company:
Unclassified
Salary:
JobFull-timeOnsite

Job Description

Senior Validation Engineer Responsibilities:

Designing validation plans. Conducting and documenting impact and risk assessments with a full understanding of equipment/system/software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes. Maintaining (and ensuring the team maintains) clear, detailed records of qualification and validation, and change control activities for future compliance audits. Designing and executing engineering studies for critical process parameter definition and verification prior to validation. 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 utomated 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.

Requirements:

Must be willing to work onsite in Kalamazoo, MI. Bachelor’s Degree or equivalent required. 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. Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate. Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization. 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. Experience in GMP regulated environment. Proven attention to detail and organization in project work. Capable of working on assigned tasks without mentorship. Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
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Dice Id:

91116760

Position Id:

262e901e6d6309972c36d55fb5a7bac0

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