Senior Validation Engineer

Overview

On Site
Full Time

Skills

Change Control
Regulatory Compliance
Auditing
Risk Assessment
UI
Testing
Test Scripts
URS
IQ
OQ
PQ
MI
Marketing Intelligence
Reporting
Collaboration
Microsoft Office
Conflict Resolution
Problem Solving
Critical Thinking
Management
Documentation
Editing
Microsoft Excel
Microsoft PowerPoint
Communication
GMP
Attention To Detail
Mentorship

Job Details

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.
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