Job Information
System One Quality Engineer II in west point, Pennsylvania
Job Title: Quality Engineer II
Location: West Point, PA
Hours/Schedule: Mon- Fri 8am- 5pm
Type: Contract
Overview
Global pharma company looking to hire experienced Quality Engineer ASAP! Must bring a BS Degree in Engineering or Life Sciences and 2+ years of experience with deviation and investigation writing.
Responsibilities
Authors, supports, updates, and/or leads documentation updates such as SOPs, batch records, change control documents, technical protocols, validation documents and other GMP documentation
Supports deviations, including assessment of product impact and determination of root cause and corrective/preventative actions, assists in writing of investigations as well as quality incidents.
Supports equipment, and facility projects for various Sterile Supply Departments at the West Point site.
Supports continuous improvement projects that increase compliance, reduce cost, and/or simplify/standardize the process.
Examines complex issues from diverse perspectives (safety, compliance, automation, equipment, process, and people) to best understand and resolve the root cause.
Designs, conducts, and/or reviews and approves experimental protocols as needed.
Provides on-the-floor support of complex operational and technical (process/equipment) issues.
Completes and/or leads projects to improve the performance of our Company processes, including investigation and execution of Corrective/Preventative Actions (CAPAs); projects aimed at improving Right-First-Time performance or preventing/reducing deviations; and projects that seek to improve efficiency, reduce cost, or increase compliance.
Supports team safety, environmental, and compliance objectives.
Manages project timelines to ensure key compliance and customer due dates are met; escalates any potential delays and develop remediation plans when possible.
Partners effectively with Operations, Quality, Planning, project teams, and external vendors.
Requirements
B.S. or B.A. in Engineering, Sciences, or related discipline.
2-4 yrs experience (combination of co-op/Real world acceptable).
Strong Technical Writing Skills, highly developed communication, Leadership and teamwork skills, Ability to manage projects/work to schedule/deadlines.
Preferred Experience and Skills: Experience in biologics, vaccine, or bulk sterile manufacturing facilities, Change Control experience, Deviation Management Investigation.
Benefits
System One offers eligible employees health and welfare benefits coverage options, including medical, dental, vision, spending accounts, life insurance, voluntary plans, and participation in a 401(k) plan.
System One, and its subsidiaries including Joulé, ALTA IT Services, CM Access, TPGS, and MOUNTAIN, LTD., are leaders in delivering workforce solutions and integrated services across North America. We help clients get work done more efficiently and economically, without compromising quality. System One not only serves as a valued partner for our clients, but we offer eligible full-time employees health and welfare benefits coverage options including medical, dental, vision, spending accounts, life insurance, voluntary plans, as well as participation in a 401(k) plan.
System One is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, age, national origin, disability, family care or medical leave status, genetic information, veteran status, marital status, or any other characteristic protected by applicable federal, state, or local law.