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.