Computer System Validation (CSV) Specialist

Allendale County, SC - USA

Monthly Salary: Not Disclosed

Posted on: Yesterday

Vacancies: 1 Vacancy

Job Summary

Our team members are at the heart of everything we do. At Cencora we are united in our responsibility to create healthier futures and every person here is essential to us being able to deliver on that purpose. If you want to make a difference at the center of health come join our innovative company and help us improve the lives of people and animals everywhere. Apply today!

Job Details

Summary of Role:

Responsible for the MES Support and validation services. Primary focused on Syncade recipe configuration and validation. For this opportunity the resource will be working collaboratively with cross-functional teams including Manufacturing Quality Automation and IT to ensure systems are configured tested and maintained in compliance with GMP and Computer System Validation (CSV) requirements.

Responsibilities:

Supporting Syncade recipe configuration and maintenance version control and lifecycle management (e.g. Recipe Authoring Equipment Tracking Material Management Workflow Inventory)
Configure and maintain MES modules and workflows ensuring alignment with site and global standards.
Configure and support MES integrations with ERP and automation systems (e.g. SAP DCS middleware).
Provide configuration-level troubleshooting and support root cause analysis for MES-related issues.
Execute and support CSV deliverables associated with Syncade configuration changes including but not limited to: Risk assessments URS / FRS reviews test plans and test scripts and IQ / OQ / PQ execution and summary reports.
Prepare and ensure validation documentation complies with GMP CSV and ALCOA data integrity principles.
Support change control impact assessments deviations and CAPA activities related to MES.
Support data validation and reconciliation activities for MES-related reports.
Participate in project meetings design reviews and deployment activities.

Shift: Administrative (Available to work or provide support to a 24/7 manufacturing operation as required)

Location: Carolina PR

Education: Bachelors degree in Science or Engineering

Preferred Qualifications:

5 years of experience in CSV in regulated environments
3 years of hands-on experience with MES platforms preferably Emerson Syncade including development and maintenance of BI solutions.
Computer systems integrations and validation experience in regulated operations (preferably GMP operations).
Strong experience authoring and executing validation documentation (test scripts protocols reports).
Excellent technical and quality documentation skills in English including validation deliverables and test evidence.
Able to use a logical systematic approach to problem solving.
Ability to manage multiple priorities and work independently with limited supervision.
Strong communication teamwork and collaboration skills.

This position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.

What Cencora offers

We provide compensation benefits and resources that enable a highly inclusive culture and support our team members ability to live with purpose every addition to traditional offerings like medical dental and vision care we also provide a comprehensive suite of benefits that focus on the physical emotional financial and social aspects of wellness. This encompasses support for working families which may include backup dependent care adoption assistance infertility coverage family building support behavioral health solutions paid parental leave and paid caregiver leave. To encourage your personal growth we also offer a variety of training programs professional development resources and opportunities to participate in mentorship programs employee resource groups volunteer activities and much more. For details visit time

Equal Employment Opportunity

Cencora is committed to providing equal employment opportunity without regard to race color religion sex sexual orientation gender identity genetic information national origin age disability veteran status or membership in any other class protected by federal state or local law.

The companys continued success depends on the full and effective utilization of qualified individuals. Therefore harassment is prohibited and all matters related to recruiting training compensation benefits promotions and transfers comply with equal opportunity principles and are non-discriminatory.

Cencora is committed to providing reasonable accommodations to individuals with disabilities during the employment process which are consistent with legal requirements. If you wish to request an accommodation while seeking employment please call 888.692.2272 or email . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies

Affiliated Companies: Echo Consulting Group Inc

Required Experience: