C&Q Specialist

Validation & Engineering Group Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical Biotechnology Chemical Food and Medical Devices industries in the following areas: Laboratory Compliance Computer Engineering Project Management Validation and other services.

We are seeking a talented dedicated individual committed to work under the highest ethics standards for the following position:

• C&Q Specialist

Position Summary

The C&Q Specialist will support commissioning and qualification activities associated with capital projects and technical initiatives within regulated pharmaceutical and biotechnology manufacturing environments.

This role is responsible for supporting protocol development field execution activities equipment startup support commissioning and qualification documentation and coordination activities associated with regulated systems and operational readiness initiatives.

Projects may support one or more of the following areas: manufacturing systems process equipment packaging systems clean utilities facilities cleanroom environments process improvements utilities infrastructure automation-related systems or other regulated operational systems.

The role requires strong technical documentation skills field coordination capabilities and collaboration with Engineering Operations Quality contractors vendors and project teams to support compliant project execution activities.

Key Responsibilities

• Support assigned commissioning and qualification.
• Generate review and execute commissioning and qualification protocols and related technical documentation.
• Support field execution activities including commissioning support verification activities and operational readiness coordination.
• Participate in FAT & SAT activities equipment inspections field walkthroughs and startup support activities as required.
• Support collection review and organization of commissioning and qualification documentation and test records.
• Document test results and execution activities in accordance with applicable GMP and data integrity expectations.
• Support identification documentation and follow-up of deviations punch-list items corrective actions and technical observations during execution activities.
• Coordinate with Engineering Operations Quality contractors vendors and project teams to support project execution and turnover activities.
• Support scheduling and coordination of field execution activities testing activities and resource needs.
• Participate in project meetings and support communication of execution status technical issues risks and action items.
• Support continuous improvement initiatives related to commissioning qualification documentation and operational readiness activities.
• Ensure commissioning and qualification activities are performed in alignment with applicable site procedures GMP requirements safety rules policies and project expectations.

Qualifications & Experience

• Bachelors degree in Engineering Science Business Administration or related technical field preferred.
• Minimum of 2 years of relevant C&Q validation startup or field execution experience required for candidates with Engineering or Science degrees.
• Candidates with Business Administration or other non-technical degrees should have a minimum of 3 years of relevant experience.
• Experience supporting one or more of the following areas is preferred: manufacturing systems process equipment packaging systems clean utilities facilities cleanrooms automation systems or regulated operational infrastructure.
• Familiarity with commissioning and qualification documentation protocol execution technical field support and GMP documentation practices.
• Familiarity with GMP regulations data integrity principles (ALCOA) and regulated documentation practices.
• Familiarity with systems such as Kneat Bluebeam TrackWise CMMS platforms or similar technical and quality systems is preferred.
• Excellent verbal and written communication skills in both English and Spanish including technical writing protocol documentation and communication of technical deliverables.
• Strong organizational troubleshooting analytical and problem-solving skills with the ability to support multiple priorities and field activities simultaneously.

Additional Requirements

• Ability to work on-site in the eastern region of Puerto Rico.
• Must be eligible to complete client-required onboarding training and site access requirements.
• Ability to work effectively within fast-paced and highly regulated environments.

The above statements describe the general nature and level of work performed and do not represent an exhaustive list of responsibilities.

At Validation & Engineering Group people always come first. We believe that when youre empowered to do your best work bold ideas thrive and real progress happens. This isnt just a job - its an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven supportive team.

Excited to build something meaningful together We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race color religion sex sexual orientation gender identity national origin veteran status or disability status.