Validation Specialist
4 weeks ago
We are seeking a highly skilled Validation Engineer to join our team at PCI Pharma Services. As a Validation Engineer, you will be responsible for the qualification and validation of pharmaceutical equipment, processes, and test methods for the assembly, inspection, testing, and packaging of medical devices.
Key Responsibilities- Manage validation projects, generate and execute validation protocols, and evaluate statistical criteria to determine validation acceptance.
- Directly interface with internal and external customers, regulatory agencies, and other departments to define, prioritize, schedule, and complete validation projects.
- Develop and execute validation documentation, including Installation/Operation/Performance/Test Method Qualification protocols, parameter pages, statements, and risk assessments.
- Ensure efficient validation documentation completion, accuracy, and closure, including organizing and coordinating multiple approvals in a timely manner.
- 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 and 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 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 and apply statistical methods to determine and evaluate 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.
- Bachelor's Degree in a related field and/or 4-5 years of related experience and/or training.
- MUST HAVE experience with the development and execution of validation protocols in the pharmaceutical and/or medical device industry.
- Statistical and Advanced Mathematical Skills.
- Intermediate Computer Skills.
- Full Professional Proficiency.
- Highest Reasoning Ability.
- Ability to work on multiple projects at the same time.
- Ability to meet aggressive timelines.
- Good interpersonal/teamwork skills.
- Effective communication skills (verbal and written form).
- Good documentation practice.
- Proficient in the use of computer software - Microsoft (Windows, Word, Excel, Outlook, PowerPoint), Minitab Statistical Software, and SPC software.
- Ability to effectively present information to various people.
- Ability to identify and resolve problems promptly.
- Ability to display original thinking and creativity.
- Ability to show success in managing employees.
- Ability to demonstrate attention to detail.
- Ability to set and achieve challenging goals.
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