Commissioning, Qualification & Validation Specialist (CQV)

Cencora Inc

Juncos

JOB DETAILS
SKILLS
Behavioral Health, Biology, Biotech and Pharmaceutical, Change Control, Chemistry, Cleanroom, Commissioning, Compensation and Benefits, Consulting, Corrective and Preventative Action (CAPA) Systems, Current Good Manufacturing Practice (cGMP), Data Quality, Documentation, Equal Employment Opportunity (EEO), FDA Requirements, Futures, Genetics, Industry Standards, Laboratory Equipment, Laboratory Systems, Maintain Compliance, Manufacturing, Manufacturing Equipment, Manufacturing Operations, Medical Equipment, Microbiology, Process Validation, Regulations, Regulatory Compliance, Risk Analysis, State Laws and Regulations, System Start-Up, Team Building, Technical Writing, Validation Documentation, Writing Skills
LOCATION
Juncos
POSTED
30+ days ago

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!\n \nJob Details\n \nSummary of Role:\n \nWe are seeking Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment.\n \nThis role is open to Engineers, Scientists, and Validation Specialists with experience supporting equipment, utilities, laboratory systems, or facilities qualification.\n \nThe selected consultant will support protocol development, execution, and validation documentation, ensuring compliance with cGMP regulations and industry standards.\n \nResponsibilities:\n\n Support Commissioning, Qualification, and Validation (CQV) activities.\n Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.\n Assist with equipment startup and commissioning activities.\n Author and review validation documentation, including protocols, reports, and discrepancy resolutions.\n Ensure compliance with cGMP regulations, FDA guidelines, and internal quality systems.\n Participate in risk assessments and impact assessments related to validation activities.\n Support change control, deviations, and CAPA investigations when required.\n Collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams.\n Ensure compliance with Good Documentation Practices (GDP) and data integrity principles.\n \nShift: Administrative Administrative (Available to work or provide support to a 24/7 manufacturing operation, as required)\n \nLocation: Multiple locations in Puerto Rico\n \nEducation: Bachelor's degree in Engineering, Chemistry, Microbiology, Biology, or related scientific discipline.\n \nPreferred Qualifications:\n\n 2+ years of experience in validation, commissioning, qualification, or regulated manufacturing environments.\n Knowledge of cGMP regulations and validation lifecycle.\n Experience supporting IQ/OQ/PQ execution or validation documentation.\n Strong technical writing and documentation skills.\n \nExperience supporting qualification of:\n\n Manufacturing equipment\n Laboratory instruments\n Utilities systems\n* Facilities or cleanroom environments\n \nThis position is for a fixed term contract supporting one of ECHO Consulting Group (a Cencora company) partners on site at their facility.\n \nWhat Cencora offers\n \nWe 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\n \nFull time\n \nEqual Employment Opportunity\n \nCencora 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.\n \nThe 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.\n \nCencora 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\n \nAffiliated Companies\n \nAffiliated Companies: Echo Consulting Group Inc

About the Company

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Cencora Inc