Validation Engineer

2 weeks ago

Hillsboro, United States Katalyst HealthCares & Life Sciences Full time

Responsibilities:

B.A. or B.S. degree (preferably in Engineering or Life Science) and at least two years of experience in the pharmaceutical or biopharmaceutical industry, or an equivalent combination of education and experience.

Basic knowledge of engineering principles and concepts applicable to Process as they relate to system performance, regulatory agency.

Some Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA), is preferred.

Ability to work collaboratively in cross-functional teams to achieve milestones and goals.

Basic knowledge of EU and US CGMPs and applicable validation guidance.

Ability to make sound decisions about quality and technical subjects.

Ability to communicate clearly and professionally both in writing and verbally.

Provide technical review and approve validation deliverables ensuring proper study design and execution.

Maintain the compliance status of the assigned validation areas at a state of inspection readiness.

Working with multiple functions, leading solution of validation issues following cGMP regulations and the client's standards.

Site Quality technical and regulatory subject matter expert and technical leader for validation study methods, design, and regulatory requirements.

Provide Quality Assurance oversight to Validation, Revalidation, and Quality Risk Management projects to meet good business practices and the requirements of applicable Health Authorities.

Assist in the integration of the risk management program with quality systems including, but not limited to, Validation, CAPA, Change Control, APQR, Complaints, and Inspection Readiness.

Provide technical review and approve validation deliverables ensuring proper study design and execution.

Maintain the compliance status of the assigned validation areas at a state of inspection readiness.

Requirements:

Working with site and corporate level functions, serve as the Quality representative in the design and implementation of area and cross-functional projects and initiatives.

Support the validation program during regulatory agency inspections.

Troubleshoot and support the resolution of Quality issues by fostering effective interdepartmental and cross-functional partnerships.

Be accountable for behaviors as described in the client's Competencies.

Provide input into the design and presentation of validation performance metrics.

Must be able to work independently and organize and manage projects by demonstrating progress against defined milestones and schedules.

Provide Quality oversight (including technical requirements and regulatory expectations) of site validation efforts.

Review and approve validation documents (e.g., Project Plans, User Requirements, Protocols, Validation Deviations, Summary Reports, etc) for CGMP and technical content.

Provide technical guidance for study design including sampling plans, acceptance criteria, and rationale.

Provide technical and quality validation assessment and approval for engineering and process changes.

Collaborate with departments to ensure validation activities are executed compliantly, with efficiency and effectiveness.

Review, assess, and approve Quality Risk management documents.

Participate in the risk stages of procuring new equipment.

Collaborate with departments to ensure risk management and validation activities are executed efficiently and effectively.

Review and approve Alarm Review documentation.

Provide input into investigations with potential validation impact.

Provide input and collaborate with other site/functional units and Corporate on validation standards and procedures.

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