Computer System Validation (CSV) Specialist

Location: Carolina, Puerto Rico

Time Type: Full time

Job Description

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: Bachelor’s 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 day. In 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 https://www.virtualfairhub.com/cencora

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 company’s 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 [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

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