Summary of Role:

We are seeking an experienced Commissioning & Qualification (C&Q) Engineer to support qualification activities for analytical and microbiology laboratory equipment within a regulated pharmaceutical biotechnology or medical device manufacturing environment. The consultant will be responsible for protocol development and execution of equipment qualification activities ensuring compliance with cGMP regulations FDA expectations and industry best practices.

Responsibilities:

• Lead and support Commissioning & Qualification activities for laboratory equipment and utilities.
• Develop review and execute Installation Qualification (IQ) Operational Qualification (OQ) and Performance Qualification (PQ) protocols.
• Perform impact assessments and risk assessments related to equipment qualification.
• Support equipment startup and commissioning activities.
• Ensure compliance with cGMP regulations FDA guidelines and internal quality procedures.
• Author and review validation documentation including protocols reports and discrepancy investigations.
• Collaborate with Quality Assurance Engineering Validation and Laboratory teams.
• Support change control deviation investigations and CAPA implementation when required.
• Ensure adherence to data integrity principles (ALCOA / ALCOA).

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

Location: Multiple locations in Puerto Rico

Education: Bachelors Degree in Engineering Chemistry Microbiology or a related scientific discipline.

Preferred Qualifications:

• 3 years of experience in commissioning qualification or validation within pharmaceutical biotechnology or medical device industries.
• Strong understanding of cGMP FDA regulations and validation lifecycle.
• Experience generating and executing IQ OQ and PQ documentation.
• Strong technical writing and documentation skills.
• Experience working under FDA EMA or other regulatory inspections.
• Familiarity with ASTM E2500 risk-based validation approaches.
• Knowledge of 21 CFR Part 11 and data integrity requirements.
• Experience with equipment lifecycle management.

Hands-on qualification experience with one or more of the following laboratory systems is preferred:

• Analytical Laboratory Equipment
• HPLC / UPLC
• Gas Chromatography (GC)
• Dissolution Systems
• TOC Analyzers
• UV-Vis Spectrophotometers
• Analytical Balances

Microbiology Laboratory Equipment:

• Incubators
• Autoclaves
• Biological Safety Cabinets
• Stability Chambers
• Environmental Chambers
• Refrigerators and Freezers
• Particle Counters

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 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

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 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 returned

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