Manager, Validation

POSITION SUMMARY

The Manager, Validation is responsible for being a hands-on leader to the validation staff as they perform qualification activities needed to meet company objectives. The role requires demonstrated ability to lead and align the validation team's efforts to meet dynamic and competing company priorities. This role must be proficient at developing validation protocols, executing protocols, creating summary reports, and managing validation activities in FDA regulated biopharmaceutical environments.

ESSENTIAL FUNCTIONS

• Provide leadership and technical support for the validation group and work with Validation Associate Director to define, recommend, and justify validation budgets, capacity, personnel, and capital equipment needs,
• Plan, coordinate and track the progress of validation projects,
• Interface with management personnel in Engineering, Manufacturing, Regulatory Affairs, etc.
• Oversee and support commissioning, cleaning validation, process validation and equipment qualifications for new and existing equipment, utilities, and facilities,
• Interact and collaborate with cross-functional departments to define qualification requirements needed to meet company objectives,
• Establish project timelines and expectations, ensuring compliance to validate parameters
• Participating in implementation of Validation policies and procedures,
• Generate and execute validation protocols (IQ/OQ/PQ/PV/CV) for production equipment, laboratory equipment, utilities, facilities, and other related systems in an FDA regulated environment, as needed.
• Review and approve SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems,
• Lead validation scope planning meetings, as needed, to define qualification requirements for new and complex equipment,
• Maintain schedules for all GMP systems to ensure that they are requalified/revalidated on time,
• Oversee and Manage team and contractors to support multiple projects with shifting priorities,
• Train end-users on validation policies and requirements to support GMP operations,
• Perform risk assessments per QRM for GMP systems as required,
• Perform deviations, change controls, and CAPAs as required per QMS,
• Report on Validation Metrics to Quality Management Review,
• Utilize Six Sigma Lean ideology on Validation approaches,
• Mentor, coach, and train validation staff on validation practices, policies, and procedures required to support GMP operations,
• Collaborate with Talent Acquisition to identify outside agencies to help support projects on an as needed basis,
• Collaborate with clients, CMO’s, and vendors to meet project and company objectives,
• Participate in audits and regulatory agency inspections for Validation,
• Serve as subject matter expert in all aspects of Validation,
• Lead investigations related to validation discrepancies and assured thoroughness of investigation, documentation, and closure,
• Create work orders, as needed, to ensure that calibrations, maintenance, and repairs are completed as required, to carry out qualification activities,
• Managing staff by setting objectives, creating development plans, and completing performance reviews,
• Collaborate and support the CSV team to validate computer systems
• Supports and oversee domestic ImmunityBio sites Validation activities
• Implement qualification practices to align with industry standards and look for streamlined approaches for process improvement and increased throughput
• Perform ad-hoc and cross-functional duties and/or projects assigned to support business needs and provide developmental opportunities.

Education and Experience

• Bachelor’s degree in science or related discipline is required.
• 10+ years of relevant validation or GMP‑regulated industry experience is required.
• Experience with facility commissioning and validation of equipment and facilities is required.
• 5+ years of management experience is preferred.
• Experience with facility commissioning and validation of equipment and facilities is required.

Knowledge, Skills, & Abilities

• Effectively plan and organize work activities and prioritize task completion to meet schedules and deadlines,
• Demonstrated ability to interface with senior leaders and cross-functional teams; is attentive and approachable.
• Excellent organization and communication skills, both written and verbal,
• Excellent knowledge and strong experience with commissioning, qualification and validation of equipment, utilities, and facilities,
• Strong knowledge of process validation principles
• Strong experience in project management concepts,
• Knowledge of Total Quality Management (TQM) philosophy,
• Critical thinking and demonstrated problem-solving / root cause investigation skills,
• Excellent technical document writing and reviewing with team,
• Experience with and knowledge of related quality systems such as change control, work order management systems, and document control is required.
• Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11 and cleanrooms, automated biopharmaceutical processing and plant equipment
• Experience with ELLAB data loggers and systems

Working Environment / Physical Environment

• This position is on-site.
• Exposure to onsite in-lab environment
• Must be able to don and wear Personal Protective Equipment (PPE) as required
• Lifting, standing, climbing, bending, grasping, sitting, pulling, pushing, stooping, stretching, and carrying are generally required to perform the functions of this position
• Must possess mobility to work in a standard office setting and to use standard office equipment, including a computer.
• Must be able to lift frequently lift up to 35 pounds and occasionally lift/move 50 pounds