Senior Computer System Validation Csv Jobs in Puerto Rico

Summary of Role:

Will play a critical role leading the design, construction, commissioning, Startup, qualification, validation, training and operation of CO2 Cold Chain (Cold Rooms/Refrigeration systems.

This role partners closely with Site Facility & Engineering (F&E), Packaging operations, Warehouse, Quality, Technologies/DTI/IT and external cold room vendors to ensure Cold Room/Refrigeration systems and processes are designed, implemented, and operated in compliance with cold room specifications as well as GxP, safety, and quality requirements. The engineer will serve as a technical subject matter expert and contribute to the development of reliable, scalable, and compliant cold chain solutions.

Responsibilities:

• Lead the design of Cold Room/Refrigeration systems and processes used in Manufacturing, Packaging and Warehouse operation
• Ensure the cold room design meets engineering, safety, quality, and regulatory compliance specifications and requirements.
• Lead commissioning, qualification, validation, startup and operation of new AOH ASRS cold room with CO2.
• Lead and support the development, testing, implementation, validation, and operation of critical automation and software systems.
• Support Commissioning, Qualification, and Validation (CQV) activities for the cold room systems.
• Lead cold room operational training and system adoption
• Partner with Quality Assurance, Computer System Validation (CSV), Packaging, Manufacturing, and IT/OT teams to maintain GxP compliance.
• Serve as a recognized Engineering Subject Matter Expert (SME) for cold room systems, establishing operational methodologies and best practices.
• Ensure commissioning and qualification activities align with project requirements, milestones, and schedule commitments.
• Apply engineering principles and practices across cold room automation, controls and integrated systems.
• Drive continuous improvement to simplify and optimize cold room design and operational processes.
• Demonstrate a strong understanding of OT/IT convergence, industrial networks, and system integration.
• Work closely with cold room vendors/consultants, ensuring contracts, technical specifications, and deliverables meet requirements.
• Effectively lead and influence teams, achieving both technical outcomes and strong collaboration.

Education: BS in engineering

Preferred Qualifications:

• Bachelor's or Master's degree in Mechanical Engineering or related discipline
• 10+ years in Industrial Refrigeration and Cold room Design
• 5+ years in CO2 cold room design and operation
• Proficiency in Automated processes, technologies and systems deployment and adoption
• Strong project management and communication skills
• Strong knowledge of cGMP and validation processes.
• Experience working in an operational GxP-regulated environment with a strong understanding of applicable regulations and standards
• Direct experience working in regulated environments (GMP, OSHA, EPA)
• Willingness to travel (30%), as required; Fluent in English with effective communication skills

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

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

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 hrsc@cencora.com. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned