Validation Engineer

Validation Engineer at IntelliPro Validation Engineer at IntelliPro in Raleigh, North Carolina Posted in 4 days ago.

Type:

full-time

Job Description:

Job Title:

Validations Contractor -

GMP Quality Assurance Location:

RTP NC Duration:

42 Weeks Onsite 40 hrs/week Pay rate: $53/hr Job Responsibilities Work alongside department customers on development, implementation, and integration of Equipment and Computer Systems Validation plans for site wide equipment onboarding Provide timely quality support and thorough reviews and approvals of various records including, but not limited to Change Controls; SOPs; analytical method, equipment and computer system qualification and validation plans, protocols, and summary reports; batch records; QC data; non-conformities and Corrective Action/Preventive Action (CAPAs) Ensure QA related activities are performed within the associated project timeline Effectively escalate concerns to area and project management Report on applicable key metrics to drive continuous improvement in compliance Participate in project meetings as a quality lead and support colleagues by acting as a technical resource for quality and compliance related issues Effectively collaborate in team environment(s) to ensure timely resolution of compliance and process concerns associated with equipment/computer systems validation activities Maintain Quality Systems in support of QMS and GMPs, including: Review and approve SOP drafts and revisions Process change controls Support equipment and computer system qualification and validation activities and vendor management program Communicate project status to stakeholders and escalate issues in a timely manner About you: Bachelor's degree in a scientific field 5+ years of experience in pharmaceutical, biotech, or biologics GMP regulated manufacturing environment with 3+ years in Quality and/or Manufacturing Solid understanding of GMP guidelines and Quality Systems with the ability to apply GMPs in conformance to US standards, and where appropriate, other regulatory authority standards Ability to author, review, and interpret Standard Operating Procedures (SOPs) Ability to identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible, and constructive manner Strong attention to detail, highly organized and the ability to multitask in a fast-paced, highly interactive environment Ability to manage workload effectively in order to meet project timelines Excellent verbal and written communication skills, and the ability to effectively collaborate with peers including scientific/technical colleagues Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint)

About Us:

Founded in 2009, IntelliPro is a global leader in talent acquisition and HR solutions. Our commitment to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships sets us apart. We continue leading global talent solutions with a dynamic presence in over 160 countries, including the USA, China, Canada, Singapore, Japan, Philippines, UK, India, Netherlands, and the EU. IntelliPro, a global leader connecting individuals with rewarding employment opportunities, is dedicated to understanding your career aspirations. As an Equal Opportunity Employer, IntelliPro values diversity and does not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status. Moreover, our Inclusivity Commitment emphasizes embracing candidates of all abilities and ensures that our hiring and interview processes accommodate the needs of all applicants. Learn more about our commitment to diversity and inclusivity at https://intelliprogroup.com.

Compensation:

The pay offered to a successful candidate will be determined by various factors, including education, work experience, location, job responsibilities, certifications, and more. Additionally, IntelliPro provides a comprehensive benefits package, all subject to eligibility.