A MES Specialist is needed for a multinational biotechnology company that specializes in the discovery, development, and delivery of therapies for the treatment of neurodegenerative, hematologic, and autoimmune diseases to patients worldwide in the Research Triangle Park, NC area. This MES Specialist will focus on Computer Systems Validation (CSV) documentation, execution, and compliance for a GxP Syncade MES implementation at a pharmaceutical facility.
location: Durham, North Carolina
job type: Contract
salary: $71.94 - 83.07 per hour
work hours: 8am to 5pm
education: Bachelors
responsibilities:
- Supporting the Large-Scale Manufacturing (LSM) Modernization project for bringing a new Manufacturing Execution System (MES) to the drug substance manufacturing area.
- There will be several phases covering electronic equipment tracking, electronic batch records and release by exception functionalities.
- Support the quality engineering workstream and activities associated with ensuring the site is ready to receive this change and sustain it within routine production operations.
- Review and provide support for the execution and documentation of the CSV Program at the RTP facility in support of all aspects of the Computer Systems Validation (CSV) Lifecycle.
- Ensure communication of project deadlines and performance standards for the Quality team are met.
- Respond to inquiries from management, and end users and provide status updates on a frequent basis.
- Plan, contribute and collaborate on CSV activities.
- Keep current of regulatory requirements that may have an impact on CSV.
- Review and approval of computer systems in the field including manufacturing and automation systems.
- Work with Automation Engineering and system owners to resolve deviations that occur during testing activities.
- Information will be communicated to the Senior Manager of Quality Engineering.
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qualifications:
- Experience level: Experienced
- Education: Bachelors
skills:
- Validation
- Quality
- Compliance
- Testing
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.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including: medical, prescription, dental, vision, AD&D, and life insurance offerings, short-term disability, and a 401K plan (all benefits are based on eligibility).
This posting is open for thirty (30) days.
