C&Q Specialist

Pinnaql, Inc.; Juncos (PR); Presencial; USD 75 000 - 95 000; Tempo integral

Resumo da oferta

Validation & Engineering Group, Inc. is seeking a C&Q Specialist in Puerto Rico to support commissioning and qualification activities for regulated pharma/biotech manufacturing.

You will develop protocols, perform field execution, and coordinate with Engineering, Operations, Quality, contractors, and vendors. The role requires strong documentation, bilingual communication, and the ability to manage multiple field activities in a fast-paced, compliance-driven environment.

Qualificações

• Bachelor’s degree in Engineering, Science, Business Administration, or related technical field preferred.

Responsabilidades

• 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.

Conhecimentos

Bilingual EN/ES

Organizational skills

Analytical skills

Problem solving

Multitasking

Formação académica

Bachelor’s degree in engineering/science/business

Ferramentas

Kneat

Bluebeam

TrackWise

CMMS

Descrição da oferta de emprego

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

• Bachelor’s 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 you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

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.