Validation Manager at Phlow Corp

Petersburg, Virginia, United States -

Full Time

Start Date

Immediate

Expiry Date

18 May, 26

Salary

0.0

Posted On

17 Feb, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

CQV Strategy, Validation Master Plans, Commissioning, Qualification, Cleaning Validation, Stability Programs, Regulatory Compliance, Risk-Based Validation, ICH Q9, Process Validation, CPV, Technology Transfer, Data Integrity, CAPA Management, FMEA, Project Management

Industry

Pharmaceutical Manufacturing

Description

Description Leadership & Strategy Develop and implement site-wide CQV strategies aligned with regulatory and business objectives. Cleaning validation Stability programs Packaging configurations for intermediate and finished goods. Lead, mentor, and develop CQV engineers and validation specialists. Establish validation master plans (VMPs) and lifecycle validation programs. Manage CQV budgets, schedules, and resource planning. Commissioning & Qualification Oversee commissioning and qualification of: Manufacturing equipment Clean utilities (WFI, clean steam, compressed gases) HVAC systems and cleanrooms Laboratory systems Process automation and control systems Establish and implement cleaning validation requirements. Establish and implement packaging configurations Stability programs and protocols Ensure execution of URS, FRS, DS, FAT, SAT, IQ, OQ, and PQ protocols. Coordinate with Engineering, Quality, Manufacturing, and external vendors. Validation Lifecycle Management Ensure compliance with: FDA 21 CFR Parts 210/211, 11 EU GMP Annex 1 & 15 ICH guidelines ISPE Baseline Guides Oversee process validation, cleaning validation, and continued process verification (CPV). Support technology transfer and new product introductions (NPI). Documentation & Compliance Review and approve validation protocols and reports. Ensure data integrity and adherence to ALCOA+ principles. Support internal audits, regulatory inspections, and client audits. Manage deviation investigations, CAPAs, and change controls related to CQV. Risk Management Apply risk-based validation approaches (ICH Q9). Conduct and facilitate FMEAs and risk assessments. Implement continuous improvement initiatives in validation processes. Requirements Education Bachelor’s degree in Engineering, Pharmaceutical Sciences, or related technical field (Master’s preferred). Experience 8+ years of experience in pharmaceutical/biotech manufacturing. 5+ years in CQV/validation leadership role. Strong knowledge of GMP-regulated environments. Experience supporting regulatory inspections. Technical Skills Deep understanding of validation lifecycle approach. Expertise in cleanroom and sterile manufacturing qualification (preferred). Knowledge of automation systems (DeltaV, Siemens, etc.). Familiarity with Kneat, ValGenesis, TrackWise, or similar systems (preferred). Soft Skills Strong leadership and team management skills. Excellent communication and stakeholder engagement abilities. High attention to detail and organizational skills. Ability to manage multiple complex projects simultaneously. Key Competencies Regulatory Compliance Expertise Project Management Risk-Based Thinking Cross-Functional Collaboration Problem Solving & Decision Making Continuous Improvement Preferred Certifications: PMP (Project Management Professional) ASQ Certified Quality Engineer (CQE) ISPE membership or relate industry certifications Physical Requirements Majority of time spent in a manufacturing environment with potential exposure to chemicals and controlled substances. Must be able to wear appropriate PPE and occasionally lift up to 30 pounds. May be required to be on call or work off-hours to support 24/7 operations.

Responsibilities

This role involves developing and implementing site-wide CQV strategies, leading validation programs for equipment, utilities, and systems, and mentoring engineering staff. The manager will oversee the execution of URS through PQ protocols and ensure compliance with all relevant regulatory guidelines.