CQV Engineer

6 days ago

Delhi, India Pharmatek Consulting Inc Full time
Job DescriptionDesigning 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

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

Requirements

Must be willing to work onsite in The Woodlands, TX (Houston area)

5-7 years of demonstrated CQV experience in GMP regulated (preferably Cell and Gene Therapy) environments

Obvious business maturity and interpersonal skills to be able to communicate effectively and collaborate

Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client’s organization

Proven attention to detail and organization in project work

Capable of working on assigned tasks without mentorship

GMP and Good Documentation Practice training (may be completed at onboarding)

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

RequirementsCell & Gene Therapy , Validation, IQ, OQ, CFR, FDA, GMP

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