Your Role: Manage and execute the Validation Program for the site. Responsible for validation of equipment and processes. Manage the Validated System Change Control Program. Supports projects required for the expansion, improvement and modernization of the production facility. Establish time lines and determine resources need to complete protocols. Implements projects within budget and schedule.
ESSENTIAL JOB FUNCTIONS
Direct the content and structure of the Validation and Change Control program.
Provide leadership for the content of validation projects and validation protocols.
Lead validation projects including planning, scheduling, execution, and project communication. Provide guidance and technical information to support activities to include dry powder product processes, cleaning validation, and utility system validation.
Proactive leadership role setting and updating site validation policies and SOPs to meet industry standards.
Key member of multi-department teams as the Validation Subject Matter Expert (SME) bringing new products/processes on-line or troubleshooting and/or improving existing products/processes.
Trouble shoot and direct the resolution of Validation issues by fostering effective inter-departmental and cross-functional partnerships.
Determine validation rationale for testing of equipment, systems, and processes.
Present and defend validation documents to customers during audits.
Manage execution of routine validations to pre-determined schedule.
Assess new product Cleaning and Process Validation against current database.
Work independently to assemble protocols, and analyze test data, summarize data into final reports, and bring projects to a timely conclusion.
Review change controls for equipment, utilities and processes and assess any effects to the validation.
Develop validation project schedule, manage project to same, and provide routine project updates.
Take part in and contribute to a safe working environment by following corporate and departmental safety regulations.
Other job related duties as required.
Who You Are
Education: B.S. Degree in Life Sciences or Engineering
Experience: 5 - 7 years cGMP experience, preferably 3 - 5 years direct validation experience
Skills and Knowledge:
Sound knowledge of bioscience processes and equipment, in a cGMP environment.
Ability to communicate clearly and professionally, both in writing and verbally.
Strong technical and problem solving skills.
Good project management skills.
Expertise in the principles of validation.
Demonstrated knowledge of the Kaye Validator and temperature data loggers.
Good computer skills
Job Requisition ID: 176704
Career Level: D - Professional (4-9 years)
Working time model: full-time
Job Segment: Developer, Database, Project Manager, Technology