Validation Sr. Manager

## Validation Sr. Manager Apply locations:
New Albany, OHtime type:
Full time posted on:
Posted 2 Days Agojob requisition :
R-103252
** Essential Duties and Responsibilities
** Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities to this job at any time.

Strategic Validation Leadership
* Develop and implement site or enterprise validation strategies aligned with operational, regulatory, and business objectives.
* Lead lifecycle validation programs to sustain the qualified and validated state of facilities, systems, utilities, equipment, and manufacturing processes.
* Establish and maintain Validation Master Plans (VMPs), validation policies, governance structures, and risk-based validation methodologies.
* Drive continuous improvement initiatives to enhance compliance, operational efficiency, reliability, and inspection readiness.
* Ensure validation strategies support commercial manufacturing continuity, product launches, and business growth.

Validation Program Oversight Provide leadership and oversight for:
* Equipment qualification (DQ, IQ, OQ, PQ)
* Process validation and continued process verification (CPV)
* Cleaning validation and contamination control strategies
* Facility, utility, and HVAC qualification
* Aligns validation activities with (CSV) computerized system validation
* Packaging, serialization, and labeling validation
* Environmental monitoring and aseptic process validation support
* Commissioning, qualification, and validation (CQV) activities

Additional responsibilities include:

* Approve validation protocols, reports, acceptance criteria, and technical justifications.
* Ensure timely execution of validation deliverables supporting operational priorities and capital projects.
* Oversee deviations, investigations, change controls, risk assessments, and remediation activities associated with validation systems.
* Ensure data integrity and documentation practices meet current GMP expectations.

Compliance & Inspection Readiness
* Ensure compliance with current GMP regulations, industry guidance, and global regulatory expectations.
* Lead site validation readiness for regulatory inspections, customer audits, and internal compliance assessments.
* Serve as subject matter expert during regulatory inspections and audit interactions.
* Partner with Quality and Compliance teams to address CAPAs, deviations, observations, and remediation plans.
* Ensure validation systems align with quality risk management and data integrity expectations.

Leadership & Organizational Development
* Lead, coach, and develop validation managers, engineers, specialists, and technical staff.
* Establish departmental objectives, staffing plans, performance metrics, and succession planning initiatives.
* Manage department budgets, contractor resources, and prioritization of validation activities.
* Foster a high-performance culture emphasizing accountability, technical excellence, collaboration, and compliance.

Cross-Functional Collaboration Partner with Manufacturing, Engineering, Quality, Regulatory, Automation, Supply Chain, and Project Management teams to support:
* New product introductions
* Technology transfers
* Facility expansions and startup activities
* Capital projects and equipment implementation
* Process optimization and continuous improvement initiatives
* Product lifecycle management
* Provide strategic validation guidance during deviations, investigations, change management, risk assessments, and remediation programs.

Technical Governance & Risk Management
* Establish and maintain risk-based validation frameworks using scientific and quality risk management principles.
* Govern validation standards, methodologies, and lifecycle execution across the organization.
* Ensure consistency in validation practices and technical decision-making.
* Lead validation review boards, escalation pathways, and governance forums as appropriate.
* Perform any other tasks/duties as assigned by management.
** Education Requirements and Qualifications
** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill and/or ability required.###

Required Qualifications
* Bachelor’s degree in Engineering, Pharmaceutical Sciences, Chemistry, Biology, Microbiology, or related scientific discipline required; advanced degree preferred.
* 10+ years of validation experience within regulated pharmaceutical, biotechnology, medical devices, or sterile manufacturing environments.
* 5+ years of leadership or people management experience.
* Strong expertise in qualification, process validation, cleaning validation, computerized systems, risk management, and GMP quality systems.
* Demonstrated success leading large-scale validation programs and cross-functional initiatives.
* Strong knowledge of global regulatory expectations and validation lifecycle concepts.###

Preferred Qualifications
* Experience supporting sterile…