Draft and implement Quality System documentation designed to establish good validation practices within the organization.
Author URS, IQ, OQ and PQ protocols and execute them in compliance with GDP guidelines and internal quality standards.
Design validation approaches, supported by appropriate statistical analyses, perform and/or coordinate all validation activities, analyze and assemble results, and draft validation reports.
Provide input on user and/or functional requirements of current and future processing equipment, and draft appropriate documentation. Additionally, interface with Contract Manufacturers to ensure all relevant user and functional requirements are met.
Provide support to non-engineering Staff, including those from R&D and Manufacturing, to ensure successful technology transfer and continuous improvement.
Execute assigned duties on time and pro-actively telegraph delays and other issues to validation manager and other relevant stakeholders.
Comply with all regulatory, corporate, and Quality System policies
Requirements
B.S. / M.S. in engineering or another relevant discipline.
Minimum of 5+ years of experience working within a medical device environment or other FDA regulated environments. Experience with device-biologic combination products is highly desirable.
Experience in the areas of Design Documentation (URS, FRS, DS, and other engineering specifications), Validation (IQ, OQ, PQ, PV, CSV, MVP, etc.), Quality Systems (Change Control, Non-Conformances, Requalification, etc.)
Understanding of c.G.x.P principles and familiarization with ISO 13485, ISO 14971, and 21C.F.R.820
Working knowledge of Computer Systems Validation lifecycle and documentation.
Proficient in Microsoft Word, Excel, PowerPoint.
Must be able to work independently with adequate supervision, multi-task, and support several projects simultaneously.
Must demonstrate strong communication, interpersonal and teamwork skills.
A strong understanding of technical writing and presentation skills is required.
About the Role
About the Company
Core, a Unicon Company, is a dynamic organization dedicated to providing innovative GxP compliance solutions to the life sciences industry. We are seeking talented and creative individuals to join our team and contribute to our continued success. We are committed to fostering a diverse and inclusive workplace where individuals from all backgrounds feel valued and respected. Our team is dedicated to delivering exceptional results and driving innovation in the field.
As an Equal Opportunity Employer, we do not discriminate employees and applicants on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status. Ready to join our team? Apply today through the link below.