Commissioning & Qualification Specialist

Manatí, PR
Autónomo
Tiempo completo

Hace 1 mes

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 DetailsSummary 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.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.

Location: Manatí, PREducation:
Bachelor’s degree or higher in Chemistry/ Biology/ Microbiology/ Computer Science/ Information Systems/ Engineering or related discipline.Preferred Qualifications:

Background in pharmaceutical products manufacturing environment and in laboratories areas
More than three (3) years of 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)

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 offersWe 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, visitFull timeEqual Employment OpportunityCencora 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 . We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returnedAffiliated Companies Affiliated Companies: Echo Consulting Group Inc

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