CQV Engineer(Onsite) Location: Holly Springs, North Carolina

CQV Engineer (Onsite)

Location:Holly Springs, North Carolina

Interview:Phone+Skype

Job Description:

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

Requirements:

• 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