Project Manager - Validation

Flexible & Integrated Technical Services, LLC • Juncos, PR

3d

About The Position

This role is for Project Management - Validation and Change Controls Services. The ideal candidate will have a Bachelor’s or Master’s degree in Engineering, Microbiology, Biotechnology, or a science-related field, with at least five years of experience in commissioning and qualification, preferably in Drug Product processing. A strong understanding of Qualification, Validation Lifecycle, and regulatory requirements is essential. The role requires proficiency in both Spanish and English communication, experience in Project Management within the Pharmaceutical Industry, and familiarity with CDOCS, TrackWise, and Kneat systems. Experience managing and supporting Change Control programs, including Validation Plans and activities, is also required. The ideal candidate is a multi-tasking, organized individual who thrives under pressure, possesses a strong understanding of project management methodologies and lifecycle execution, values teamwork, and operates with a high degree of ethics.

Requirements

• Bachelor’s / Master's degree in Engineering, Microbiology, Biotechnology, or a science-related field
• At least five (5) years of experience in commissioning and qualification, preferably in Drug Product processing
• Understanding of Qualification, Validation Lifecycle, and regulatory requirements
• Spanish and English communications
• Experience in Project Management within the Pharmaceutical Industry
• Proficiency with CDOCS, TrackWise, and Kneat systems
• Experience managing and supporting Change Control programs
• Strong experience in Validation Plans and Validation activities, including Change Controls
• Multi-tasking abilities
• Ability to work under pressure
• Organized
• Knowledge of project management methodologies and lifecycle execution
• Teamwork skills
• Ethical conduct

Responsibilities

• Lead and administer the Validation Assessment Forum.
• Serve as the primary point of contact for Validation Assessment requestors and Change Control Owners.
• Maintain forum agenda, decision log, action log, and open item tracker.
• Coordinate and schedule validation assessments based on priorities, change control due dates, resource availability, and business risk.
• Maintain the Validation Assessment Smartsheet as the source tracker for assessment status, ownership, due dates, dependencies, action items, and escalation needs.
• Assist with Change Control Overview Presentations to perform an initial assessment to ensure assessment requests are reviewed with the right Validation and technical stakeholders.
• Support with any additional technical information not presented during the Change Control Overview needed during Validation Assessment generation.
• Compile and prepare Change Control Validation Plans using technical input and assessment conclusions provided by Validation and subject matter experts.
• Maintain routine communication with Change Control Owners, Validation, area stakeholders, and Validation leadership on priorities, risks, dependencies, and progress.
• Identify risks to meeting Validation Team goals and escalate issues that may affect schedule, compliance, quality, or change control closure timelines.
• Develop and maintain performance metrics for Validation Team support of the Change Control process.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level