Job Description

Job Title: Senior Validation Specialist

Location: Lakewood, Colorado

Type: Long-Term Contract

Key Responsibilities:

• Serve as a subject matter expert in overseeing the setup and readiness of equipment, utilities, and cleanroom facilities used in pharmaceutical production.
• Take ownership of key validation documents such as DQ, FAT, SAT, IQ, OQ, and PQ — from writing to execution.
• Perform hands-on testing in the field to ensure systems function as intended.
• Contribute to the development of Project Validation Plans (PVPs) that outline the testing and verification approach.
• Drive the validation process through each project phase, ensuring deliverables are met on time and according to compliance standards.
• Maintain working knowledge of current regulatory requirements and industry guidance related to systems like process equipment, clean utilities, automation, labs, and buildings.
• Organize and lead meetings across departments to keep project timelines on track and encourage collaboration.
• Facilitate involvement of cross-functional teams during system design and decision-making processes.
• Occasionally travel to vendor sites for equipment inspection and Factory Acceptance Testing (FAT).
• Be available for occasional support during construction or installation phases, which may include weekends or extended hours.
• Visit on-site construction areas, adhering to all required safety protocols and gear.
• May also assist with client relationship management, proposal support, scheduling, budgeting, and representing the company at conferences or through publications.
• Supervise third-party contractors during equipment testing.
• Support additional duties as required by the client or internal project teams.
• Must adhere to client site policies, including COVID-19 vaccination requirements, where applicable.
• Provide leadership and guidance to a team of validation professionals.

Required Qualifications:

• Strong background in validation processes, including preparation and execution of documentation such as URS, DQ, RTM, Risk Assessments, CPPs, VPPs, FATs, SATs, IOQs.
• Familiarity with risk-based validation approaches like ASTM E-2500 or ISPE ICQ.
• Hands-on experience with process and clean utility systems, ISO cleanroom environments, and process control systems such as PCS, SCADA, or Historians.
• Understanding of biotech processing equipment (e.g., bioreactors, CIP, chromatography, TFF, UF, buffer systems).
• Leadership and mentoring experience is a plus, with the ability to support and develop junior staff.
• Willingness to travel occasionally.
• Ability to manage multiple projects efficiently and work well under pressure.

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