Senior Validation Manager

Kelly Government Solutions is a strategic supplier and business partner to the federal government and its key suppliers. Kelly Government Solutions offers validation and pharmaceutical manufacturing professionals the opportunity to support Phlow, a government-backed domestic API manufacturer focused on strengthening the nation’s pharmaceutical supply chain through the reliable development and production of critical active pharmaceutical ingredients. We are seeking a Senior Validation Manager to support Phlow’s pharmaceutical manufacturing operations in Petersburg, VA.

Key Responsibilities:

• Lead and implement site-wide CQV and validation strategies aligned with operational and regulatory requirements
• Manage external validation contractors and third-party partners currently supporting validation activities
• Oversee validation efforts related to Manufacturing equipment, Clean utilities, HVAC systems and cleanrooms, Laboratory systems, Process automation and support systems
• Establish and maintain Validation Master Plans (VMPs) and lifecycle validation programs
• Ensure execution of URS, FRS, DS, FAT, SAT, IQ, OQ, and PQ protocols
• Lead revalidation activities and support site readiness as manufacturing expands
• Develop, implement, and expand cleaning validation programs, including cleaning master plans, protocols, and supporting documentation
• Support packaging configuration development for intermediate and finished goods, working closely with packaging partners and contract organizations
• Provide oversight for stability programs and protocols
• Support technology transfer and new product introductions for upcoming manufacturing programs
• Review and approve validation protocols, reports, and related documentation
• Ensure compliance with FDA, EU GMP, ICH, and ISPE guidance
• Support deviations, CAPAs, change controls, audits, and regulatory inspections
• Apply risk-based validation principles and lead validation-related risk assessments
• Work closely with operations, engineering, quality, and contractors in a highly visible, hands-on floor-based role
• Help build and scale an internal validation team as the site continues to grow

Work Schedule:

• Standard schedule is 40 hours/week
• This role is expected to be highly hands-on and floor-based, not strictly desk-based
• Flexibility may be required to support off-hours work, urgent validation activities, or 24/7 manufacturing operations
• Start date is needed as soon as possible

Qualifications:

Minimum Qualifications:

• Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, or a related technical field
• 8 years of experience in pharmaceutical or biotech manufacturing
• 5 years of experience in a validation, CQV, or related leadership role
• Strong pharmaceutical manufacturing background in a GMP-regulated environment
• Demonstrated leadership experience managing validation teams, contractors, or third-party service providers
• Strong understanding of the full validation lifecycle and regulatory compliance requirements
• Ability to manage broad validation scope across multiple functions, not just one specialty area
• Strong communication, project management, and cross-functional collaboration skills

Preferred Qualifications:

• Master’s degree in a related technical discipline
• Strong experience with cleaning validation, including development of cleaning master plans and validation documentation
• Experience in API manufacturing
• Experience in a startup, growth-stage, or site build-out environment
• Experience supporting packaging configurations and working with contract packaging organizations
• Experience with stability programs
• Experience supporting regulatory inspections and audits
• Familiarity with Kneat, ValGenesis, TrackWise, or similar systems
• Knowledge of DeltaV, Siemens, or other automation/control systems
• PMP, ASQ CQE, ISPE membership, or similar industry certification

PLEASE APPLY ONLINE

When you apply, please know a Kelly Government Solutions Recruiter will review your resume and will contact you directly, if your skills and experience match the requirements of this position; a full job description can be made available at that time.

Due to the high volume of inquiries, we regret that we cannot accept phone calls. Even if you aren’t contacted for this position, you are still part of our talent network. All Kelly recruiters have access to your profile, which expands your opportunities even further.