CQV Engineer
CQV Engineer
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1 Vacancy
Job Description
Job Title: CQV Engineer Amgen Juncos PR
Facilities / Critical & Non-Critical Utilities / New Equipment / Existing Equipment
Role Objective
We are seeking CQV Engineers to join our talent pool for multiple specialties. Selected candidates will be allocated to projects based on expertise and organizational needs supporting facilities utilities new equipment or existing equipment modifications in a highly regulated biopharmaceutical environment.
Specialized CQV Roles
1. CQV Engineer Facilities
- Experience: 5 years executing CQV activities for facilities including Functional Verification (FV) Functional Qualification (FQ) smoke studies and Environmental Monitoring Performance Qualification (EM-PQ).
- Key Skills: Walkthroughs layouts and controlled environment assessments.
2. CQV Engineer Critical & Non-Critical Utilities
- Experience: 5 years in commissioning and qualification of utilities including WFI loops clean steam process air etc.
- Core Activities: CU-PQ CQT loop checks calibrations and ECN execution.
3. CQV Engineer New Equipment
- Experience: 5 years in CQV of new equipment such as ATF RTF chromatography skids UF/DF systems and perfusion tanks.
- Responsibilities: FAT/SAT execution SIP-PQ commissioning and qualification protocol development.
4. CQV Engineer Existing Equipment
- Experience: 5 years supporting modifications of existing equipment including tie-ins tanks valves and filtration systems.
- Activities: QSR generation SIP-PQ impact assessments and documentation reviews.
Key Requirements for All Roles
- Hands-on experience with Kneat LIMS CDOCS and Maximo.
- Strong knowledge of GDP GMP and 21 CFR Part 11 regulations.
- Experience with risk-based validation and a lifecycle approach to CQV.
- Must be available to work 50 hours per week on-site at Amgen Juncos.
Core Responsibilities
- Plan execute and document Commissioning Qualification and Validation (CQV) activities for facilities utilities and equipment.
- Develop and execute risk-based validation strategies master plans protocols and technical assessments.
- Lead and support FAT/SAT/IQ/OQ/PQ CU-PQ EM-PQ CQT loop checks calibrations and post-modification validations.
- Collaborate with cross-functional teams in Engineering Operations Quality and Supply Chain to ensure operational readiness and compliance.
- Ensure adherence to GMP GDP and regulatory requirements including FDA Guidelines EU Annex 1 ASTM E2500 and ISO 14644.
- Support internal and external audits responding to regulatory findings as needed.
- Maintain accurate and timely documentation across all systems (Kneat LIMS CDOCS Maximo).
Education & Experience
- Ph.D. in Engineering Minimum 2 years CQV experience in regulated environments.
- Masters Degree in Engineering Minimum 4 years CQV experience.
- Bachelors Degree in Engineering Minimum 5 years CQV experience (required for all specialties).
Preferred Qualifications
- Strong technical writing and reporting skills.
- Demonstrated ability to manage multiple CQV projects simultaneously.
- Experience working in biotech or pharmaceutical manufacturing environments.
- Familiarity with risk assessments impact analysis and change control processes.
Summary Table
**Weil Group is proud to be an Equal Employment Opportunity Employer.*
Employment Type
Full Time
