Commissioning & Qualification Specialist
Commissioning & Qualification Specialist
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Job Description
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 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: Manat PR
Education:
Bachelors 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 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 time 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 returnedEqual Employment Opportunity
Affiliated Companies
Affiliated Companies: Echo Consulting Group Inc
Required Experience:
Unclear Seniority
Employment Type
Full-Time
