Actalent Hiring for Validation Manager at Newark Full Time

Hiring for a well established cell and gene therapy manufacturer!

Description:

• Establish the required validation programs to ensure the site meets current US regulatory expectations and are aligned with current industry best practices including the integration of appropriate risk-based strategies.

• Establish and maintain site Master Validation Plan (MVP) to describe the approaches for the required validation programs for the facilities, computerized systems, products, and processes.

• Establish and manage the respective validation projects by aligning, coordinating, and supervising the prioritization of activities against the business needs.

• Review and approved validation deliverables (protocols, risk assessments, reports, etc.) ensuring alignment with validation strategies outline in the Master Validation Plan and relevant site procedures.

• Provide input into deviations, CAPAs and Change Controls to ensure that equipment, processes, and systems remain in a validated state.

• Work with validation staff to develop risk-based validation approaches and resolve complex validation issues.

• Communicate validation requirements, timelines, and resource needs to management.

• Provide leadership and management for the validation resources through a structural process of goal setting, performance appraisal, and individual development.

• Serve as a subject matter expert (SME) for Validation during client audits and regulatory inspections.

• Oversees and manages contract services providers relating to validation projects and processes.

Skills:

• Validation

• Validation protocols

• Instrumentation

• Metrology

• IQ, OQ, PQ

• Process validation

• Computer system validation

• Equipment calibration

Experience Level:

Expert Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.