CQV Engineer
CQV Engineer
Posted on :
22-07-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
22-07-2025
Job Description
Responsibilities:
- Upstream/downstream process and CQV support (ex. autoclaves parts washers incubators Isolators HVAC).
- Managing and working collaboratively with clients quality representative to complete deviation investigation and resolution for problems and issues encountered during execution activities. Includes ability to complete root cause analysis.
- Supporting clients change management program including authoring proposed changes executing impact assessments/ regression analysis and supporting client documentation of change results and release.
- 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.
- Reading technical schematics to identify locate and test photo sensors verify part numbers and complete I/O testing on automated manufacturing equipment.
- General understanding of capital equipment implementation and process knowledge.
- Understanding validation documents URS IQ OQ PQ.
- Verifying system drawings including ability to review and as-built P&IDs (piping and instrumentation drawings) and I&C (instrumentation and controls) drawings as well as verifying electrical schematics with support of an electrical engineer.
- Bachelor of Science in Technical Field (engineering life science or equivalent) from accredited institution.
- Minimum 4 years technical experience.
- Demonstrated experience in Commissioning & Validation activities covering URS (GMP equipment).
- Demonstrated experience authoring and executing FAT SAT IOQ CSV Protocols.
- Experience in a pharmaceutical / FDA-regulated manufacturing environment. A solid working knowledge of cGMP and facility/equipment validation requirements.
- Communication Skills: Excellent oral and written communication skills including presentations.
- Ability to write clearly concisely and persuasively in a professional environment.
- Demonstrated ability to interact effectively with all levels of the organization.
- Demonstrated understanding of risk-based approach to commissioning & qualification.
- Experience with testing of automated manufacturing equipment / systems (e.g. PLC-controlled).
- 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.
- Experience in GMP regulated environment.
- Proven attention to detail and organization in project work.
- Capable of working on assigned tasks without mentorship.
Employment Type
Full-time
Key Skills
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