Overview / Responsibilities CQV Specialist (Wood Group USA, Inc., Houston, TX) (Multiple Positions):
Provide support for commissioning, qualification and validation services. Responsible for writing and executing deliverables related to pharmaceutical manufacturing. Generate documents such as design qualification, equipment, facility and utility commissioning and qualification, cleaning validation, computer validation, sterilization validation, data reviews, SOP development and development of final reports.
Full time employment, Monday - Friday, 40 hours per week. Skills / Qualifications MINIMUM REQUIREMENTS:
Employer will accept Bachelor's degree in Biology, Biomedical Engineering, Pharmacy, or related field, and 4 years of experience in job offered or in a related occupation. Alternatively, employer will accept Master's degree in Biology, Biomedical Engineering, Pharmacy, or related field, and 2 years of experience in job offered or in a related occupation.
Position requires 2 years of experience in each of the following:
- Authoring, reviewing and executing Validation deliverables, including Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) for Manufacturing and Process equipment per US-FDA guidelines.
- Reading and walking down piping and instrumentation diagrams (P&IDs).
- Understanding of and experience in the commissioning and qualification of pharmaceutical unit operations, specifically operations related to cell and gene therapy.
- Mapping of Controlled Temperature Units (CTUs) including incubators, refrigerators, and freezers, using temperature mapping equipment, including Kaye Validator, Kaye Valprobe and data loggers.
- Commissioning and qualification for pharmaceutical grade utilities including Water for Injection Storage and Distribution, HVAC related to clean room environments, and clean
compressed gases including compressed air, and nitrogen.
- Reviewing and compiling of data packs and turnover packages (TOPs) to support commissioning and qualification activities.
Travel to unanticipated sites throughout the United States is required.
TO APPLY: Click "Apply Online". Should you have any difficulty in applying for this position through our website, please scroll down to Application Assistance for additional guidance. Company Overview
Wood is a global leader in consulting and engineering, helping to unlock solutions to critical challenges in energy and materials markets. We provide consulting, projects and operations solutions in 60 countries, employing around 35,000 people. www.woodplc.com Diversity Statement
We are an equal opportunity employer that recognises the value of a diverse workforce. All suitably qualified applicants will receive consideration for employment on the basis of objective criteria and without regard to the following (which is a non-exhaustive list): race, colour, age, religion, gender, national origin, disability, sexual orientation, gender identity, protected veteran status, or other characteristics in accordance with the relevant governing laws.