Commissioning & Qualification (C&Q) Specialist (North Region)

*Overview*

We ares seeking a detail-oriented Commissioning & Qualification (C&Q) Specialist to support equipment and system qualification projects in regulated manufacturing environments.

The selected candidate will develop and manage qualification documentation, execute field verification and testing activities, document discrepancies, and prepare final reports. This position requires hands-on qualification experience, strong technical writing skills, and effective collaboration with Engineering, Manufacturing, Maintenance, and Quality teams to meet established project timelines.

*Responsibilities*

* Develop, review, and maintain validation and qualification plans for equipment and systems.
* Prepare and manage lifecycle documentation, including User Requirements Specifications (URS), system risk assessments, GxP assessments, and requirements traceability matrices.
* Support commissioning activities through installation walkdowns, equipment readiness checks, and functional verifications.
* Support Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT), as required by project scope.
* Develop, execute, and review Installation Qualification (IQ), Operational Qualification (OQ), and combined Installation and Operational Qualification (IOQ) protocols.
* Record test results and compile supporting evidence in accordance with approved protocols and good documentation practices.
* Document and investigate protocol deviations, coordinate corrective actions and retesting, and support deviation review and closure.
* Review technical drawings, equipment specifications, and supporting engineering documentation to verify consistency with installed systems and qualification requirements.
* Prepare assessments related to electronic records and electronic signatures under 21 CFR Part 11, as applicable.
* Develop or update Standard Operating Procedures (SOPs), preventive maintenance and calibration forms, and related training materials.
* Perform and document cleanability assessments, as required.
* Prepare final qualification summary reports documenting execution results, deviation status, and conclusions.
* Coordinate document review and approval workflows, maintain version control, and ensure qualification packages are complete.
* Collaborate with cross-functional teams to resolve technical issues, communicate progress, and meet project milestones.
* Perform activities in accordance with site procedures, GMP requirements, data integrity principles, and applicable safety practices.

*Qualifications*

* Bachelor's degree in Engineering, Life Sciences, or a related technical discipline preferred.
* Experience supporting FAT, SAT, and commissioning activities preferred.
* Familiarity with Computer System Validation (CSV), 21 CFR Part 11 assessments, and electronic document or validation management systems preferred.
* Experience developing SOPs, preventive maintenance and calibration documentation, training materials, and cleanability assessments preferred.
* Demonstrated experience in commissioning, qualification, or validation within pharmaceutical, biotechnology, medical device, or other GMP-regulated manufacturing environments.
* Hands-on experience developing and executing equipment or system qualification protocols.
* Experience preparing and managing validation plans, User Requirements Specifications (URS), risk assessments, deviation reports, and final summary reports.
* Ability to interpret technical drawings, equipment specifications, and supporting engineering documentation.
* Working knowledge of GMP requirements, good documentation practices, and data integrity principles.
* Experience managing qualification documentation, including version control, supporting evidence, and review and approval workflows.
* Strong technical writing, organizational, communication, and problem-solving skills.
* Ability to manage assigned deliverables independently and collaborate effectively with multidisciplinary teams.
* Availability to work on-site and flexibility to support extended hours, weekends, and holidays when required by scheduled project activities.

Join us and contribute to commissioning and qualification projects in regulated manufacturing environments. Submit your resume highlighting your experience in protocol development and execution, qualification activities, and regulatory documentation.

_Synerlution is an equal opportunity employer._

Job Types: Full-time, Contract

Education:
* Bachelor's (Preferred)

Shift availability:
* Day Shift (Preferred)
* Night Shift (Preferred)

Ability to Commute:
* Vega Baja, PR * (Required)

Work Location: In person