Contract position: Global leader in the healthcare/medical product manufacturing industry is currently looking for 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 in Mixing Equipment, Clean Room Qualifications, and Water for Injection systems. This is a contract position expected to last 12 months, could be longer based on performance, possible temp to perm. Will offer per diem. Great Contractor Benefits! Apply Now!Responsibilities for the Validation Engineer
Requirements for the Validation Engineer
- Must perform process validation, process capability, and process control studies for assigned areas
- Must support Manufacturing, Engineering, and Quality Management departments with the development and implementation of new process/technology.
- Must participate in and contribute to medium to large size projects, own assigned tasks, produce detailed requirements and analysis documents for assigned tasks. Partner with other support groups and manufacturing teams to complete work.
- Must ensure computer systems and applications follow regulatory quality standards through validations activities.
- Responsible for creating the documents required for the development and validation of computerized systems
- Must be able to understand, test, and debug applicable software while following the software life cycle procedures.
- Responsible for ensuring FDA regulations are met for system upgrades/replacements, including the 2011 FDA Guidance for Process Validation.
- BS degree in Engineering Discipline (ME, IE, CHE, BME, EE, CE) with at least 1+ year of experience.
- 3-5 years of facility related validation experience focused around commissioning and qualification
- Experience working on validation, HVAC, control rooms, filtration with a Pharm or Medical Device environment.
- Documentation experience(Writing Protocols and Reports 5. IQ / OQ / PQ & Data Integrity (ALCOA)
- Must have data integrity experience
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.