Job Details

Validation Project Manager - Texas - 6- 12 Months contractOur client, a global pharmaceutical manufacturing organization are looking for a talented Validation Project Manager to join their expanding team. With continued organizational growth and considerable investment across their portfolio and capital programs this is an extremely exciting opportunity to contribute towards their brand-new manufacturing facility on the East Coast of the United States.

Responsibilities:

• Oversee & manage validation projects/ time-lines from initiation to completion.
• Define and monitor Key Performance Indicators (KPIs) to measure validation effectiveness and report on KPIs to management and stakeholders.
• Coordinate with cross-functional teams to align on project schedules, plans, and deliverables.
• Develop schedules / project plans / meeting minutes. Provide updates as needed.
• Effectively schedule validation activities in co-operation with other departments, company priorities, and department goals.
• Coordinate resources and personnel to achieve company and department goals.
• Pre-approve and post-approve qualification protocols.
• Conduct risk analyses and identify potential risks, recommending areas of improvement.
• Ensure all validation activities comply with FDA, EMA, GAMP 5 and other relevant regulatory bodies.
• Assist in continuous improvement for the department by evaluating systems to improve functionality and efficiency.
• Execute validation protocols (as needed).
• Prepares validation master plans for facilities, equipment, and systems.
• Approves the resolution of discrepancies encountered during protocol execution.

• Proven success in managing, reviewing, authoring, and approving full life-cycle technical documentation.
• Experienced generating and executing validation activities on a range of equipment and systems.
• Proven success in project coordination/management responsibilities. Ability to effectively communicate and align team members, and schedule/develop project plans.
• Experienced in vendor coordination.
• Excellent technical writing skills.
• Strong understanding of industry regulations and requirements.
• Strong attention to detail and commitment to quality and compliance.
• Strong problem solving and analytical skills.
• Working knowledge of Microsoft Office products (Project, Outlook, Word, Excel, PowerPoint).
• Bachelor's Degree preferably in Engineering or Life Sciences
• cGMP Experience