Sr. Validation Engineer II Job at BioLife Plasma Services (Thousand Oaks)

Job Description

About the role: This position supports the operations through the initial qualification to validation maintenance of equipment, systems, facilities, and utilities. Responsible and accountable for performing activities such as Cycle Development (CD), Design Qualification, Commissioning and Qualification, Performance Qualification (PQ) / Cleaning Validation (CV), and Validation Maintenance. Focused on right first-time execution and continuous improvement.

Job Responsibility

Lead the execution of CD/PQ/CV/PV/RV activities
Act as project manager for validation deliverables ensuring new systems are implemented within predetermined timelines and financial forecasts
Supervise and manage contractors or consultants as needed
Participate in change control review board
Track and trend activities and report on issues such as impact to predetermined timelines and problems as needed
Serve as the Validation Engineering representative and technical subject matter expert (SME) on cross-functional and multi-site teams related to equipment, computerized systems, utilities, facility, and computerized systems
Apply advanced theory, technical principles, and expert judgment to address a broad range of problems
Troubleshoot and direct the resolution of Validation issues by fostering effective interdepartmental and cross-functional partnerships
Maintain a state of inspection readiness and act as SME in Health Authority inspections
Review and approval of commissioning documents, including but not limited to commissioning protocols and reports
Evaluate and leverage testing to qualification activities
Generate, execute, and manage the detailed project plans and timelines for the execution of CD/DQ/IQ/OQ/PQ/CV/Validation Maintenance, change management activities and their associated documentation
Support departmental and capital project validation activities
Provide validation key performance indicators data in a predetermined frequency
Owner of change control task of validation activities
Execute validation activities aimed at improving Right First-Time
Ensure new systems are implemented within predetermined timelines and financial forecasts
Present and provide rationale for the completed work during periodic audits and Health Authority inspections
Coordinate and perform tactical activities, including sample collection, coordinating with cross-functional support teams, retrieving data and results, completing documentation, as required per protocols
Coordinate and perform equipment and system re-qualification according to procedures and predetermined timelines
Foster an environment that encourages continuous learning
Maintain expertise as necessary to stay abreast of technical and industry advancements
Solve technical problems while maintaining required levels of safety, quality (including regulatory compliance), and production
Support EHS programs and own CAPA records as needed
Manage time effectively, prioritize tasks, set goals, and develop systems for achieving those goals
Accountable for behaviors as described in Takeda Standards, policies, and procedures
May perform other duties as assigned

Requirements

BS engineering with a minimum of 10+ years’ experience in validation
Experience with systems like LIMS, MES, ERP, SCADA, or DCS (e.g., Delta V) for computer systems validation engineers is desirable
Advanced knowledge of equipment, computerized systems, facilities, and utilities in a regulated environment is required
Advanced knowledge of commissioning and qualification of equipment, computerized systems, computerized systems, facility, and utilities is required
A problem-solving mindset with strong technical and/or engineering knowledge, as well as strong ability to work collaboratively with interfaces to Process Engineering, Quality, Project Managers, Facilities, Automation, and other groups
Technical expertise to define validation approaches and execution of system validation activities in accordance with cGMP and applicable regulations, procedures, and industry guidance
Basic understanding of data and statistical analysis of validation test results
Knowledge of cGMPs or equivalent regulations, validation associated regulations, guidelines, and best practices
Ability to independently evaluate technical situations and propose potential solutions
Ability to work independently or in teams, partners, suppliers, and customers
Ability to communicate effectively at all levels in verbal and written form, including technical/business writing
Proficient in Microsoft Word and Excel, computer software

What we offer

medical, dental, vision insurance
401(k) plan and company match
short-term and long-term disability coverage
basic life insurance
tuition reimbursement program
paid volunteer time off
company holidays
well-being benefits
up to 80 hours of sick time per calendar year
up to 120 hours of paid vacation (new hires accrual)

BioLife Plasma Services - All Job Offers

Select Country

Sr. Validation Engineer II

Job Description

Job Responsibility

Requirements

What we offer

Looking for more opportunities?

Sr. Validation Engineer II

Sr Software Engineer II, Axon Air

Ms Fabric Sr. Engineer

Sr. Network Engineer

Sr. Network Engineer

Sr. Network Engineer

Sr Clinical Engineering Medical Device Network Engineer

Sr. Maintenance- 1st Shift

Sr. Maintenance-Overnight

Our AI answers in your language