Role: Quality Validation Engineer

Location: Thousand oaks, CA

Duration: 12+ Months

Looking for:

MFG and Pharma experience

Looking for a validation quality approver, this person should have validation background, can review and approve of qualification, validation, and final report documents.

Must have a background in validation for Facility, Equipment, Critical Utility, Automation Systems, =Cleaning and Process.

Responsible for reviewing pertinent documents, against Standard Operating Procedures (SOPs) for accuracy and compliance to procedures based on regulatory requirements and internal guidelines, etc. which comprises the majority of the work performed.

Provide validation expertise and support for the development (or modification phases) of manufacturing facility, systems, process and information and Computerized System; address, include and implement all the applicable QA requirements.

Review from a quality perspective, the validation approach and documentation as required to assure compliance with procedures and regulatory submissions

Review from a quality perspective the validation documentation required to assure the proper development of a project and support regulatory submissions.

Participate in the risk assessment related to the project.

Assure requirements traceability throughout the whole project life cycle.

Evaluate, analyze, and approve protocol discrepancies and ensure that the required corrective actions are taken.

May perform other duties as assigned

Strong interpersonal skills and great attention to detail are necessary. Must be a strong team player with good problem solving, and good verbal and written communication skills. Must be able to handle multiple projects concurrently, have computer experience and have extensive knowledge of FDA Regulations and GxPs.

Must have experience in pharmaceutical/biotech validation which includes the writing and executing of protocols.

Must have experience or advanced training and demonstrate proficiency (e.g. Takeda’s quality systems such as validation, change control, etc., statistical methods/six sigma training, problem analysis and resolution, design of experiments and process development/pilot scale work).

The individual will have proficiency in plasma fractionation and purification processes.

Successful track record of analyzing complex technical problems.

Demonstrates good troubleshooting and decision-making abilities.