Validation Engineer II

Validation Engineer II

Responsibilities:

• Work individually and in teams to support capital projects and implement solutions for our clients.
• Develop and execute a variety of validation and FDA compliance related documents/protocols for pharmaceutical equipment.
• Travel to top clients across the country to assist in the design of manufacturing processes, help manage projects, develop facilities, and impact the world by conducting themselves with integrity in pursuit of individual and enterprise goals.
• Establish user requirement specification for critical equipment and systems.
• Assess risk across various aspects of systems' functions and focus efforts on critical quality aspects.
• Work with teams to perform investigations and troubleshoot issues related to validation.
• Analyze qualification data and recommend corrective actions.
• Develop & perform impact assessments, trace matrices, system risk assessments, and other risk-based validation documentation deliverables.
• Prepare validation reports.
• Assist in project planning, scheduling, and coordination.
• Provide routine communication and status updates to BW Design Group project leadership and the client.

Qualifications:

• Good communication and interpersonal skills, flexibility with tasks, and the ability to interact with all levels of management, clients, and vendors.
• Ability to work as an individual contributor as well as a team player on a large project team.
• Minimum of 3 years project experience in the pharmaceutical or medical device environments.
• Strong technical writing and oral communication skills.
• Strong computer skills (Microsoft Office, Microsoft Project, AutoCAD).
• Willing and able to travel as necessary for project requirements.
• Understanding of ICH Q7 through Q11, 21 CFR Parts 210, 211, 11, ISPE Baseline Guides, GAMP5, and ASTME
  2500.
• B.S. in Bioengineering, Biomedical Engineering, Chemical Engineering, or related technical degree.