Commissioning & Qualification (C&Q) Specialist

Cencora • Puerto Rico, TX

21h • Onsite

About The Position

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: Provide Commissioning, Equipment Qualification (IOQ), Computer System Validation (CSV), Forms and SOP execution services.The resources will work with oversight from the Quality Control Laboratory, Computer System Validation Information Technology team, the Lab Management, and will interact on a regular basis with Engineering, Technical Services and Quality Assurance representatives as well as reporting progress to the Project Engineering department.

Requirements

• BS or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/ Engineering or related discipline.
• More than 5 years of experience working with PLC’s, Industrial Computers with experience in commissioning and validating laboratory and manufacturing computerized systems in a manufacturing environment, and training in validation methodologies, technologies, and process control computer systems.
• Knowledge on computerized system with data collection software (database).
• Strong knowledge of cGMP, GAMP, SDLC, FDA, 21 CFR Part 11 and Data Integrity Regulations.
• Knowledge in MS Project Management and MS Visio programs.
• Experienced in Instrument Performance qualification, and method configuration
• Excellent skills writing commissioning/ validation, and technical documentation in English and using MS Office applications.
• Bilingual (both English/Spanish)

Nice To Haves

• Background in pharmaceutical products manufacturing environment and in laboratories areas

Responsibilities

• Qualification - Author and execute qualification protocols (IQ, OQ, PQ) for laboratory systems.
• Ensure qualification and validation activities meet regulatory requirements and company standards.
• Manage deviations, CAPAs, and change controls related to laboratory systems.
• Commissioning - Perform installation and operational checks for laboratory equipment and systems.
• Develop commissioning protocols and execute commissioning activities for new or upgraded laboratory systems.
• Identify and resolve technical issues during commissioning.
• Documentation - Create and maintain accurate and complete documentation, including protocols, test scripts, reports, and SOPs.
• Ensure traceability of all qualification and validation activities.
• Compliance - Ensure compliance with global regulatory standards (e.g., FDA, EMA, ICH) and industry guidelines.
• Lifecycle Management - Support the periodic review and requalification of laboratory systems.
• Coordinate system upgrades, decommissioning, and troubleshooting.
• Cross-Functional Collaboration - Partner with QC, validation, IT, and engineering teams to ensure seamless implementation.
• Provide support during regulatory audits and inspections.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level