Manager, Validation

ImmunityBio, Inc.•Dunkirk, NY

5d•$144,000 - $160,000•Onsite

About The Position

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.

Requirements

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.
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

Nice To Haves

5+ years of management experience is preferred.
Experience with ELLAB data loggers and systems

Responsibilities

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.

Benefits

Medical, Dental and Vision Plan Options
Health and Financial Wellness Programs
Employer Assistance Program (EAP)
Company Paid and Voluntary Life/AD&D, Short-Term and Long-Term Disability
Healthcare and Dependent Care Flexible Spending Accounts
401(k) Retirement Plan with Company Match
529 Education Savings Program
Voluntary Legal Services, Identity Theft Protection, Pet Insurance and Employee Discounts, Rewards and Perks
Paid Time Off (PTO) includes: 11 Holidays
Exempt Employees are eligible for Unlimited PTO
Non-Exempt Employees are eligible for 10 Vacation Days, 56 Hours of Health Pay, 2 Personal Days and 1 Cultural Day