Validation Engineers

QRC Group

Caguas, Puerto Rico

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JOB DETAILS

SKILLS

Cleanroom, Code of Federal Regulations, Commissioning, Current Good Manufacturing Practice (cGMP), Documentation, Drug Manufacturing, English Language, Equipment Validation, Failure Mode and Effects Analysis (FMEA), HVAC, Housekeeping/Cleaning, ISO (International Organization for Standardization), Leadership, Manufacturing, Manufacturing Operations, Multilingual, Multitasking, Process Validation, Quality Assurance, Requirements Validation/Verification, Risk Analysis, Spanish Language, System Validation, Technical Writing, Writing Skills

LOCATION

Caguas, Puerto Rico

POSTED

19 days ago

We are seeking Validation Engineer professionals to support validation activities for sterile manufacturing, plant operations, facilities, equipment, systems, room requalification, and project-based validation initiatives. Assignment may include one or more active site projects, depending on project need. The role includes authoring and executing protocols, supporting field execution, documenting results, resolving discrepancies, and owning validation deliverables through closeout.

Project Assignment Areas

Grade D Manufacturing Environment project, including Central Dust Extraction, Grade D area/suite qualification, and equipment relocation validations.
Bulk IPA Storage systems validation.
Fillers Relocation room requalification.
Pledget Dust Remediation dust-extraction equipment validation.
Plant operations and quality project validation scope.
Facilities-related validations for designated engineers, including HVAC, utilities, cleanroom, and BMS.

Key Responsibilities

Author and execute commissioning and qualification protocols and reports, including IQ/OQ/PQ.
Own validation deliverables through execution, discrepancy resolution, and closeout.
Execute field activities and document results in accordance with applicable validation requirements.
Support equipment, systems, facilities, utilities, cleanroom, room requalification, and project validation activities as assigned.
Perform risk-based assessments and support FMEA activities where applicable.
Coordinate validation deliverables with QA, Engineering, and Manufacturing.
Support multiple concurrent projects, depending on assignment.

Requirements

Required Qualifications

Bachelor’s degree in Engineering or a related technical field.
Minimum 5 years of validation experience in a regulated environment.
Hands-on IQ/OQ/PQ authoring and execution experience.
Experience supporting equipment, systems, facilities, utilities, cleanroom, and/or regulated manufacturing validation.
Working knowledge of cGMP and 21 CFR 210/211.
Strong technical-writing skills.
Ability to work on-site in El Paso, Texas.
Bilingual English/Spanish preferred.

Preferred Qualifications

Sterile / combination drug-device manufacturing background.
Experience with Kneat.
ISO 14971 / FMEA experience.
Cleanroom / ISO 14644 experience.
Validation leadership experience, where applicable.

Validation Engineers

QRC Group

Caguas, Puerto Rico

Requirements

About the Company

QRC Group

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