Quality Validation Engineer

Overview

The Validation Engineer is responsible for the qualification/validation of pharmaceutical equipment, processes, and test methods for the assembly, inspection, testing, and packaging of medical devices. Core functions include management of validation projects, generation and execution of validation protocols, evaluation of statistical criteria to determine validation acceptance, direct interface with internal/external customers/regulatory agencies, and determination of external customer validation needs. Requires the ability to work with other departments to define, prioritize, schedule, and complete validation projects such that PCI’s internal/external compliance standards and production targets are achieved.

Occasional overtime/weekend work is required.

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The essential duties and responsibilities include the following but other duties may be assigned.

• Write, review, and/or execute validation documentation (e.g., Installation/Operation/Performance/Test Method Qualification protocols, parameter pages, statements, risk assessments) for the assembly, inspection, testing, and packaging of medical devices to assure compliance with regulatory, internal, and customer requirements.
• Ensure efficient validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals in a timely manner as required.
• Serve as the primary validation representative for medical device packaging and assembly. Conduct and/or participate in customer conference calls, customer/regulatory audits and inspections, and face-to-face meetings.
• Interact with Sales, Project Management, Engineering, Maintenance, Production, Technical Services, Quality Assurance, and external customers to determine requirements for new projects
• Effectively communicate project goals and progress to internal/external clients. Investigate deviations, document in formal reports, and assure resolution of corrective action to complete the validation.
• Participate in the change management process, outline requirements for validation through impact assessments, and prepare change control and validation history reports for audits.
• Review and approve pre-validation documents including, but not limited to, User Requirement/Acceptance Testing, Factory/Site Acceptance Testing, Engineering Studies, and batch records/packaging instructions.
• Apply engineering and statistical principles, theories, and techniques proficiently to support the validation of equipment, processes, and test methods for medical device assembly, inspection, testing, and packaging.
• Measure characteristics of medical devices (e.g, force, time, weight, length) and apply statistical methods (e.g., Gage Repeatability and Reproducibility (Gage R&R), Attribute Agreement Analysis, Cluster Analysis, One-Way Analysis of Variance (ANOVA)) for determining and evaluating acceptance criteria.
• Support the validation of new technology/instrumentation with a focus on Data Integrity principles.
• May participate and/or assist in conducting Factory Acceptance Tests (FAT) and Site Acceptance Tests (SAT) to qualify new equipment.
• Will be required to complete and pass GDP and GMP training courses.
• This position may require overtime and/or weekend work.
• Attendance to work is an essential function of this position.
• This position may require extra hours and/or weekend work.
• Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules, and requirements.
• Performs other duties as assigned by Manager/Supervisor.

The requirements listed below are representative of the knowledge, skill, and/or ability required for the stated position. Reasonable accommodation may be made to enable individuals with disabilities to perform essential functions.

Required:

• Bachelor's Degree in a related field and/or 4-5 years of related experience and/or training.
• Must have a minimum of at least three years of experience in an FDA-regulated industry with a strong preference for medical devices or combination products
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• MUST HAVE experience…