Validation Engineer II

Empower Pharmacy•Houston, TX

1d•Onsite

About The Position

Validation Engineer II drives compliance and manufacturing readiness across Empower’s 503A and 503B operations through validation activities supporting sterile and non-sterile manufacturing. This role manages equipment qualification, process validation, computer system validation, and compliance documentation ensuring regulatory readiness and operational scalability. 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.

Requirements

Strong expertise in validation lifecycle management, CQV activities, equipment qualification, process validation, computer system validation, and regulatory compliance.
Proficiency using AI-enabled analytics tools, validation software, quality management systems, Microsoft Office applications, and digital documentation platforms.
Advanced knowledge of cGMP regulations, GAMP guidance, 21 CFR Part 11 requirements, sterilization validation, cleaning validation, and risk-based validation methodologies.
Strong analytical, project management, communication, and problem-solving skills with the ability to manage multiple priorities and maintain compliance standards.
Bachelor of Science degree in Engineering, Pharmaceutical Sciences, Biology, Chemistry, or related scientific discipline required.
Minimum 3 years of validation experience within pharmaceutical, biotechnology, healthcare, or regulated manufacturing environments preferred.
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.
Demonstrated ability to execute with precision, adapt quickly to operational demands, and contribute effectively within high-performance environments.

Nice To Haves

Certified Quality Engineer (CQE) or equivalent certification preferred.

Responsibilities

Manages validation activities for equipment, facilities, processes, utilities, and computer systems supporting compliant manufacturing operations.
Utilizes AI-enabled analytics and workflow automation to improve execution consistency, issue resolution, and validation performance.
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.
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.
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.
Supports change control, CAPA implementation, deviation investigations, and quality events impacting validated systems and processes.
Applies AI-powered trend analysis and risk assessment tools to improve root cause identification and corrective actions.
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.
Supports qualification and operation of sterilization, cleaning, lyophilization, and manufacturing systems supporting production readiness and validation requirements.
Utilizes AI-enabled monitoring tools to improve system reliability and process performance.
Partners with Manufacturing, Engineering, Quality, Regulatory Affairs, Research and Development, and contractors supporting CQV activities.
Applies AI-enabled collaboration platforms and analytics to improve communication, issue resolution, and project success.
Identifies opportunities to improve validation methodologies, documentation processes, and operational efficiency.
Utilizes AI-powered analytics and automation technologies to strengthen validation effectiveness, compliance execution, and business performance.