5950 - Senior CQV Engineer / Senior Validation Engineer 2

Description

Verista’s 500 experts team up with the world’s most recognizable brands in the life science industry to solve their business needs. The nature of our business is to empower growth and innovation within the scientific community and to help researchers, organizations, and companies solve some of the world’s most pressing healthcare challenges. Verista provides innovative solutions and services that empower informed decision-making and are the result of our significant investment in our people and our capabilities.

Our ability to grow is driven by world-class people who thrive in a team environment and share our mission to enable life sciences clients to improve lives. Our talented and dedicated professionals are committed to making an impact every day.

Company Culture Guidelines & Values:

• We empower and support our colleagues
• We commit to client success at every turn
• We have the courage to do the right thing
• We encourage an inclusive environment where our colleagues feel respected, engaged, and challenged.
• We constantly acquire new skills and learn from our experiences to enhance our collective expertise

CQV Engineer Responsibilities (Typical):

• Downstream process and CQV support (ex. Chromatography, Centrifugation, Product Pooling, Filtration Systems)
• Developing and reviewing, and SOP documentation
• 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 PowerPoin