Position Summary
We are seeking an experienced
CQV Specialist to support a critical retrofit and qualification project within a sterile pharmaceutical manufacturing environment. The selected candidate will be responsible for planning, coordinating, documenting, and executing Commissioning, Qualification, and Validation (CQV) activities associated with equipment modifications, automation integration, calibration, and qualification deliverables for GMP-regulated systems.
Key Responsibilities- Lead and execute commissioning, qualification, and validation activities for capital and retrofit projects within a sterile pharmaceutical manufacturing environment.
- Develop, review, and execute commissioning and qualification documentation, including: Validation Plans, Commissioning Protocols, IQ, OQ, and PQ Protocols, Traceability Matrices, Risk Assessments, Final Reports and Summary Reports
- Support startup, operational readiness, and GMP implementation activities.
- Coordinate CQV deliverables related to mechanical, electrical, instrumentation, automation, calibration, and software modifications.
- Ensure equipment and systems are installed, tested, operated, and maintained according to design requirements, user requirements, and intended operational use.
- Provide qualification support for equipment upgrades, communication interfaces, PLC modifications, instrumentation replacements, and calibration activities.
- Work closely with OEM representatives, project engineering teams, automation engineers, validation personnel, quality groups, and contractors during project execution.
- Support change control, deviation investigations, CAPA implementation, and qualification impact assessments.
- Verify compliance with current Good Manufacturing Practices (cGMP), industry standards, and site quality procedures.
- Utilize digital validation platforms and electronic lifecycle management tools for documentation and execution of CQV activities.
- Participate in project meetings and provide updates regarding CQV progress, risks, and mitigation plans.
- Ensure all technical and validation documentation is completed accurately and in accordance with regulatory expectations.
Required Qualifications- Bachelor's Degree in Engineering, Life Sciences, or a related technical discipline.
- Minimum of 5 years of experience in Commissioning, Qualification, and Validation (CQV) within the pharmaceutical industry.
- Proven experience supporting projects in sterile pharmaceutical manufacturing environments.
- Strong background in commissioning and qualification activities for GMP-regulated facilities, utilities, equipment, and automation systems.
- Experience with startup and operational readiness activities.
- Strong knowledge of cGMP regulations, validation lifecycle methodologies, and pharmaceutical compliance requirements.
- Experience with digital validation solutions and lifecycle management tools such as ALM or equivalent systems.
- Ability to prepare and review technical and validation documentation in English.
- Proficiency with Microsoft Office applications (Word, Excel, PowerPoint, Outlook).
- Strong technical writing and documentation skills.
- Excellent communication and coordination abilities.
- Fully bilingual (English and Spanish).
