Position SummaryThe Principal Validation Engineer is responsible for coordinating all validation activities by constant communication with affected departments and personnel; oversees and reviews validation area processes and procedures. Prepares all protocols, executing of protocols and reports for validation work in an FDA regulated biopharmaceutical environment. This includes management of contractors as they supplement validation staff during expansion activities.
Essential Functions- Provide validation focused design and development by engaging with cross-functional teams to define requirements, design, verification and validation plan and strategies.
- Generate and execute validation protocols (IQ/OQ/PQ) of all site equipment including laboratory equipment, production equipment, utilities (as applicable) and other related systems in an FDA regulated environment.
- Provide technical project management for certain phases of a project such as scheduling, design, engineering specifications, drawings, and materials procurement.
- Author and review SOPs, protocols, reports, and validation master plans for GMP equipment, instruments, and computerized systems.
- Perform risk assessments for GMP systems as required and plan validation efforts according to risk.
- Evaluate systems for potential process improvements utilizing Lean Six Sigma or Quality by Design approaches as applicable.
- Supports managers hold delivery teams accountable for their assignments.
- Manage contractors, projects and timelines. Coordinate multiple projects and shifting priorities.
- Mentors and guides a team of junior Validation Engineers in the validation work performed across multiple teams and projects.
- Train end users on validation policies and requirements to support GMP operations.
- 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 qualification and validation.
- Troubleshoot and coordinate failure investigations for manufacturing and laboratory equipment.
- Assist with vendor communications and maintenance/repair scheduling.
- Resolve deviations and non-conformances reported during validation/qualification.
- Assist with engineering studies and investigations in other departments and perform any additional responsibilities as requested or assigned.
- Generate and keep current inventory of GMP systems and requalification/revalidation schedules.
- Create, edit and adhere to Standard Operating Procedures (SOPs) and process improvements as needed.
- Performs ad-hoc and cross-functional duties and/or projects as 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 and equipment commissioning, qualification and validation is required.
Knowledge, skills and Abilities - Excellent technical document writing and reviewing with teams.
- Excellent knowledge of validation principles including commissioning, IQ/OQ/PQs related to equipment and facilities.
- Experience with and knowledge of related quality systems such as change control; CAPA (including deviations/OOSs); Risk Assessment (FMEA): training and document control are required.
- Experience with ELLAB data loggers and systems (preferred)
- Working knowledge of GMPs, OSHA compliance, 21 CFR Part 11 and cleanrooms, automated biopharmaceutical processing and plant equipment
- Working knowledge of Lean Six Sigma and/or Quality by Design approaches
- Good interpersonal skills and the ability to work well independently and collaboratively.
- Excellent communication and organizational skills
- Able to work independently and collaboratively with other business partners and contractors
Working Environment / Physical Environment- This position works on site as noted in their offer letter.
- 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
This position is eligible for a discretionary bonus and equity award. The annual base pay range for this position is below. The specific rate will depend on the successful candidate's qualifications, prior experience as well as geographic location.
$148,500 (entry-level qualifications) to $165,000 (highly experienced) annually
The application window is anticipated to close on 60 days from when it is posted or sooner if the position is filled or closed.
ImmunityBio uses artificial intelligence (AI) tools to assist with sourcing and identifying potential candidates for open positions. These tools help us reach qualified applicants and improve the efficiency of our recruitment outreach. No preference is given to applicants sourced or identified by AI tools.
Important: AI is not used to screen, evaluate, rank, assess, or make hiring decisions about applicants. All applications are reviewed by human recruiters and hiring managers. Hiring decisions are made solely by ImmunityBio personnel without automated decision-making.
