Contract position: Will offer per diem. Global leader in the healthcare/medical product manufacturing industry is looking a Validation Engineer in Marion NC to provide hands on validation support to several facility/utility and equipment qualifications that are planned for the site. This validation engineer will need to have experience with qualification of control software and data retention related to the manufacturing processes for Injectables, Mixing Equipment, Clean Rooms, and Water for Injection systems. This is a contract position expected to last 10 months, could be longer based on performance. Currently we are only looking for local candidates. Great Contractor Benefits! Apply Now!Responsibilities for the Validation Engineer
Requirements for the Validation Engineer
- Responsible for ensuring FDA regulations are met for system upgrades/replacements, including the 2011 FDA Guidance for Process Validation, and Data Integrity CFR21 part 11.
- This position will be implementing software driven systems while working with engineering and IT
- Must ensure computer systems and applications follow regulatory quality standards through validations activities.
- Must be able to understand and ideally assist with debug of applicable software while following the software life cycle procedures.
- Must perform process validation, process capability, and process control studies for assigned projects
- Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new process/technology.
- Will participate in and contribute to medium to large size projects, own assigned tasks, produce detailed requirements and analysis documents for assigned tasks.
- BS degree in Engineering Discipline (ME, IE, CHE, BME, EE, CE) with at least 3 years of software focused validation experience.
- IQ / OQ / PQ & Data Integrity (ALCOA)
- Familiar with Rockwell platforms such as Wonderware, Allen-Bradley PLC, and Factory Talk View
- Knowledge of applications such as MS Office: Word, Excel, PowerPoint, Outlook, Microsoft Project,
- Working knowledge process instrumentation in the pharmaceutical industry desired
- Paid Vacation
- Health Insurance, and more...
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.