CQV Engineer

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

A CQV Engineer, will be responsible for commissioning, qualifying, and validating computerized systems, ensuring they meet regulatory requirements and industry standards.

Responsibilities

• Develop, execute, and manage commissioning, qualification, and validation (CQV) activities for computerized systems in a pharmaceutical environment.
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements for all computerized systems.
• Collaborate with cross-functional teams, including IT, Quality Assurance, and Operations, to ensure systems meet user requirements and functional specifications.
• Author and review validation documentation, including validation plans, protocols, and reports (e.g., URS, FRS, DQ, IQ, OQ, PQ).
• Conduct risk assessments and implement mitigation strategies to ensure system compliance and data integrity.
• Troubleshoot and resolve issues related to computerized systems, ensuring minimal disruption to operations.
• Maintain up-to-date knowledge of regulatory guidelines, such as GAMP 5, FDA 21 CFR Part 11, and EU Annex 11, to ensure systems are validated in accordance with industry standards.

Location: Manati, PR

Education: Bachelor’s or Master’s degree in Engineering, Computer Science, or a related field.

Preferred Qualifications:

• 3-5 years of experience in CQV and CSV activities within the pharmaceutical or biotech industry.
• Strong knowledge of GMP, GAMP 5, FDA 21 CFR Part 11, and EU Annex 11 regulatory requirements.
• Proven experience with computerized system validation (CSV) and data integrity principles.
• Excellent technical writing skills for creating and reviewing validation documentation.
• Strong analytical and problem-solving skills, with the ability to work independently and collaboratively in a team environment.
• Effective communication and interpersonal skills to interact with cross-functional teams and stakeholders.

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 https://www.virtualfairhub.com/cencora

Equal Employment Opportunity

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 [email protected]. We will make accommodation determinations on a request-by-request basis. Messages and emails regarding anything other than accommodations requests will not be returned

Affiliated Companies

Originally posted on Himalayas

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