CQV Engineer-W2 ONLY

Title: CQV Engineer
Location: Holly Springs, NC-onsite
Duration: 6-12+ Months

CQV Engineer Responsibilities (Typical):
* 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:
* Must be able to meet onsite work requirements in Holly Springs, NC
* 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