Empower Pharmacy

Empower Pharmacy

Validation Engineer II

Houston, TX · Mid

Sponsorship not specifiedDetected 7 days ago
ComplianceProject ManagementHRISGMPFDA RegulatoryResearchLeadershipCommunicationCollaborationProblem SolvingAdaptabilityMicrosoft OfficeRegulatory Affairs

About the role

  • Leveraging AI-enabled analytics, automated workflows, predictive monitoring, and digital quality systems, the position improves decision-making, validation accuracy, and execution efficiency.
  • Success requires strategic thinking, execution rigor, learning agility, and disciplined problem solving within a hyper-growth, highly regulated environment.
  • Talent demonstrates accountability, technical expertise, collaboration, and continuous improvement supporting compliance excellence, manufacturing continuity, and business performance.

Responsibilities

  • Lifecycle Management: Manages validation activities for equipment, facilities, processes, utilities, and computer systems supporting compliant manufacturing operations.
  • Protocol Development: Develops, executes, reviews, and maintains validation protocols and reports including IQ, OQ, PQ, FAT, SAT, and process validation documentation. Applies AI-assisted tools to improve quality, traceability, and execution efficiency.
  • Compliance Support: Executes validation activities in accordance with FDA regulations, cGMP requirements, GAMP guidance, and 21 CFR Part 11 expectations.
  • Change Management: Supports change control, CAPA implementation, deviation investigations, and quality events impacting validated systems and processes.
  • Audit Readiness: Supports audits, inspections, and compliance assessments through maintenance of validation documentation and technical records. Leverages AI-assisted reporting and document management systems to strengthen readiness and documentation accuracy.
  • Equipment Operations: Supports qualification and operation of sterilization, cleaning, lyophilization, and manufacturing systems supporting production readiness and validation requirements.
  • Technical Collaboration: Partners with Manufacturing, Engineering, Quality, Regulatory Affairs, Research and Development, and contractors supporting CQV activities.
  • Strong analytical, project management, communication, and problem-solving skills with the ability to manage multiple priorities and maintain compliance standards.
  • Customer Focus: Builds trust through customer-centric solutions.
  • Optimizes Work Processes: Drives efficiency with continuous improvement.

Requirements

  • While performing the responsibilities of the job, the employee is required to talk and hear.
  • Employees are regularly required to move about the office and around the corporate campus.
  • The employee is regularly required to stand, walk, reach with arms and hands, climb or balance, and to stoop, kneel, crouch or crawl.
  • Bachelor of Science degree in Engineering, Pharmaceutical Sciences, Biology, Chemistry, or related scientific discipline required.
  • Demonstrated ability to execute with precision, adapt quickly to operational demands, and contribute effectively within high-performance environments.
  • Proficiency using AI-enabled analytics tools, validation software, quality management systems, Microsoft Office applications, and digital documentation platforms.
  • Minimum 3 years of validation experience within pharmaceutical, biotechnology, healthcare, or regulated manufacturing environments preferred.

Nice to have

  • Experience with equipment qualification, process validation, computer system validation, change control, CAPA management, and regulatory compliance activities strongly preferred.
  • Experience supporting sterile manufacturing, cleaning validation, sterilization validation, and CQV projects preferred.
  • Certified Quality Engineer (CQE) or equivalent certification preferred.

Skills

  • Applies AI-assisted tools to improve quality, traceability, and execution efficiency.
  • Oversees multiple validation projects ensuring timelines, budgets, and quality expectations are achieved.
  • Leverages AI-powered project tracking and reporting tools to improve prioritization, visibility, and project execution.
  • Compliance And Quality
  • Executes validation activities in accordance with FDA regulations, cGMP requirements, GAMP guidance, and 21 CFR Part 11 expectations.
  • Utilizes AI-enabled compliance monitoring tools to improve oversight, consistency, and inspection readiness.
  • Applies AI-powered trend analysis and risk assessment tools to improve root cause identification and corrective actions.
  • Identifies opportunities to improve validation methodologies, documentation processes, and operational efficiency.

Benefits

  • We offer comprehensive benefits to support your health, well-being, and future, including medical, dental, and vision coverage, paid time off, 401(k) matching, wellness perks, IV therapy, and compounded medications.

Company info

  • Empower Pharmacy is a visionary healthcare company dedicated to making quality, affordable medication accessible to millions of patients nationwide.
  • As the nation's most advanced 503A compounding pharmacy and FDA-registered 503B outsourcing facility, we're redefining what's possible in personalized medicine and pharmaceutical manufacturing.
  • We're proud to be recognized as one of Houston's fastest-growing private companies and ranked #116 in Healthcare & Medical on the Inc.
  • 5000 List for 2025.
  • Empowering people defines who we are.
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This listing is sourced directly from Empower Pharmacy's careers page and normalized into a canonical job model.