C&Q Consultant

myhrabc; Cidra (PR); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical, dental, and vision

Adoption assistance

Infertility coverage

Paid parental leave

Training & development

Mentorship programs

Job summary

Cencora is seeking Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in regulated pharmaceutical, biotechnology, or medical device environments. This role welcomes Engineers, Scientists, and Validation Specialists with experience supporting equipment, utilities, laboratory systems, or facilities qualification.

The selected consultant will develop, execute, and document IQ/OQ/PQ activities, ensuring cGMP compliance. Location: Cidra, PR.

Qualifications

• Experience supporting IQ/OQ/PQ execution or validation documentation.
• Knowledge of cGMP regulations and validation lifecycle.
• Strong technical writing and documentation skills.

Responsibilities

• Support Commissioning, Qualification, and Validation (CQV) activities.
• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Assist with equipment startup and commissioning activities.
• Author and review validation documentation, including protocols, reports, and discrepancy resolutions.
• Ensure compliance with cGMP regulations, FDA guidelines, and internal quality systems.
• Participate in risk assessments and impact assessments related to validation activities.
• Support change control, deviations, and CAPA investigations when required.
• Collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams.
• Ensure compliance with Good Documentation Practices (GDP) and data integrity principles.

Skills

CQV experience

Technical writing

Regulated manufacturing

Cross-functional collaboration

Education

Bachelor's degree in Engineering, Chemistry, Microbiology, Biology, or related field

Tools

IQ/OQ/PQ protocols

cGMP knowledge

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.

Job Details

Summary of Role

We are seeking Commissioning, Qualification, and Validation (CQV) professionals to support validation activities in a regulated pharmaceutical, biotechnology, or medical device manufacturing environment. This role is open to Engineers, Scientists, and Validation Specialists with experience supporting equipment, utilities, laboratory systems, or facilities qualification. The selected consultant will support protocol development, execution, and validation documentation, ensuring compliance with cGMP regulations and industry standards.

Location : Cidra, PR

Shift : Administrative (Available to work or provide support to a 24/7 manufacturing operation, as required)

Responsibilities

• Support Commissioning, Qualification, and Validation (CQV) activities.
• Develop, review, and execute Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols.
• Assist with equipment startup and commissioning activities.
• Author and review validation documentation, including protocols, reports, and discrepancy resolutions.
• Ensure compliance with cGMP regulations, FDA guidelines, and internal quality systems.
• Participate in risk assessments and impact assessments related to validation activities.
• Support change control, deviations, and CAPA investigations when required.
• Collaborate with Engineering, Quality, Laboratory, Manufacturing, and Validation teams.
• Ensure compliance with Good Documentation Practices (GDP) and data integrity principles.

Education

Bachelor's degree in Engineering, Chemistry, Microbiology, Biology, or related scientific discipline.

Preferred Qualifications

• 5+ years of experience in validation, commissioning, qualification, or regulated manufacturing environments.
• Knowledge of cGMP regulations and validation lifecycle.
• Experience supporting IQ/OQ/PQ execution or validation documentation.
• Strong technical writing and documentation skills.

What Cencora offers

• medical, dental, and vision care
• backup dependent care
• adoption assistance
• infertility coverage
• family building support
• behavioral health solutions
• paid parental leave
• paid caregiver leave
• training programs
• professional development resources
• opportunities to participate in mentorship programs
• employee resource groups
• volunteer activities

Full time

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 [e-mail] . 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: Echo Consulting Group Inc