This role is onsite from Day 1 

Job Summary

This position is a hands-on role and directs the validation organization responsible for the execution of validation activities. The ideal candidate will develop and implement harmonized validation processes and practices across the company. Develop team of Validation SMEs capable of supporting validation initiatives for clinical and commercial programs, in compliance with the company and regulatory requirements. This role covers validation/qualification of equipment, facilities, utilities, cleaning, sterilization, automated systems, and computer system validation in a cGMP environment. This individual interfaces with Process Engineering, Quality, Facilities, Automation Engineers, Project Managers, and other groups.

Requirements

• Ensure the development and implementation of validation strategies to ensure compliance with applicable regulatory requirements
• Develop and enhance validation programs and internal SOPs to reflect regulatory requirements and industry best practices
• Write and review qualification and validation documents (Validation Master Plan, SOPs, URS, IQ, OQ, PQ, validation summary reports, etc.) in compliance with Rani procedures, good scientific and statistical concepts, and regulatory requirements
• Lead and support qualification and validation of cGMP equipment, facilities, utility systems, cleaning and manufacturing processes, etc.
• Develop and maintain risk based, quality driven procedures and practices with respect to qualification/validation testing strategies and requirements. Lead risk assessment activities
• Identify, hire and develop the company’s validation expertise in all aspects of validation (equipment, cleaning, computer system validation, etc.)
• Lead validation team including consultants and contractors if applicable, and supervise executions
• Train and guide applicable personnel on industry validation practices, relevant standards and internal procedures
• Support the change control program with respect to facility, utilities, equipment, cleaning and computerized systems validation changes. Evaluate validation impact of manufacturing process changes and equipment upgrades
• Provide timely and effective completion of relevant activities in support of regulatory filings, production schedules and/or customer needs with respect to facilities, utilities, equipment, computer system validation, etc.
• Ensure Quality meets or improves on budget, cost and efficiency targets (KPI’s) in line with business objectives
• Support Quality Assurance activities related to the assigned projects, including, but not limited to: internal and external audits, deviations, change control and CAPAs
• Other duties/activities may be necessary to support departmental or company goals

Education and/or Job Experience

• Bachelor’s degree in life science or Engineering
• A minimum of 10 years of validation experience within the pharmaceutical or biotechnology industry
• At least 5 years of direct supervisory-level or managerial-level experience is required
• Must understand, follow and comply with regulatory requirements as applicable to various processes
• Knowledge of industry standards and best practices for Good Engineering Practices, FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971) and validation such as GAMP 5, 21 CFR Part 11, and ASTM E2500
• Knowledge of international and domestic cGMP regulations for pharmaceutical manufacturing operations, metrology requirements
• Strong technical writing skills and ability to create technical protocols and reports, as well as standard operating procedures
• Demonstrated creativity, effectiveness, energy in addressing major strategic challenges
• Proven track record of establishing clear expectations, setting objectives and delivering results within deadlines
• Strong problem-solving and analytical skills with strong technical and/or engineering knowledge, and a bias toward action and results
• Experience in project management

MUST HAVE

Bachelor’s degree in life science or Engineering

A minimum of 10 years of validation experience within the pharmaceutical or biotechnology industry

At least 5 years of direct supervisory-level or managerial-level experience is required

Knowledge of industry standards and best practices for Good Engineering Practices, FDA Quality System Regulations, ISO Standards (ISO 13485 and ISO 14971), and validation such as GAMP 5, 21 CFR Part 11, and ASTM E2500

Knowledge of international and domestic cGMP regulations for pharmaceutical manufacturing operations, metrology requirements