Validation Specialist

4 weeks ago


Rockford, Illinois, United States PCI Pharma Services Full time
Job Summary

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.
Requirements
  • 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.
Preferred Qualifications
  • 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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