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Summary Of Object
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 requi
red.
Essential Duties and Responsibilit ies : 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 assi
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 require
ments.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 projectsEffectively 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 weekendwork.Attendance to work is an essential function of this position.This position may require extra hours and / or weekendwork.Knowledge of and adherence to all PCI, cGMP, and GCP policies, procedures, rules, and requirements.Performs other duties as assigned by Manager / Supervisor.
Qualifica tions : 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 fun
ctions.
RequiredBachelor'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 combinationproducts.MUST HAVE experience with the development and execution of validation protocols in the pharmaceutical and / or medical deviceindustry.Statistical and Advanced Mathematical SkillsIntermediate Computer Skills : Ability to perform more complex computer tasks and know various computerprograms.Full Professional Proficiency : Ability to speak, read, and write fluently and accurately on all levels pertinent to professional needs.Highest Reasoning Ability : Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems and deal with nonverbal symbolism in its most difficult phases while dealing with concrete / abstract variables.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 documentationpractice.Proficient in the use of computer software - Microsoft (Windows, Word, Excel, Outlook, PowerPoint), Minitab Statistical Software, and SPCsoftware.
PreferredAbility to effectively present information to various people as the jo
b requires.Ability to identify and resolve problems promptly.Ability to display original thinking andcreativity.Ability to show success in managingemployees.Ability to demonstrate attentionto detail.Ability to set and achieve challenging goals.
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Equal Employment Opportunity (E
EO) Statement
PCI Pharma Services is an Equal Opportunity / Affirmative Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other pro
tected status.
At PCI, Diversity, Equity, and Inclusion (DEI) are at the core of our company’s purpose : Together, delivering life-changing therapies. We are committed to cultivating an inclusive workplace by holding ourselves accountable to the highest standards of understanding, fairness, respect, and equal opportunity – at every level. We envision a PCI community where everyone can belong and grow, and we strive to bring this vision to reality by continuously and intentionally assessing our people practices, policies and programs, marketing approach, and wor
kplace culture.
