QRC Group, Inc
Pharmaceutical, Medical Devices and Chemical Industries
Sr.Engineer
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“Sr. Engineer at QRC Group, Inc. Skills: Commissioning, Qualification, Documentation, Risk Management. Develop C&Q strategies. Define system boundaries”
Industry & Context.
Risk assessments; Deviations; CAPA
What They're Looking For.
Must Have
Experience in GMP-regulated manufacturing environments, understanding of FDA, EMA, ISPE, and ASTM guidelines, Experience with validation lifecycle documentation and risk-based qualification approaches, Excellent technical writing, communication, and collaboration skills
What You'll Do.
Develop C&Q strategies
Define system boundaries
Lead risk assessments
Execute commissioning activities
Ensure systems installed
Coordinate startup activities
Approve commissioning documentation
Oversee protocol execution
Ensure documentation compliance
Maintain document lifecycle
Support data integrity
Prepare validation reports
Lead risk assessments
Manage change controls
Develop characterization protocols
Execute characterization activities
Develop characterization reports
How You'll Work.
Team & Collaboration
Partner with Engineering, Validation, QA, Manufacturing, Supply Chain; Interface with system owners; Provide technical guidance; Support project meetings; Support status reporting; Support stakeholder communications
Communication Scope
Excellent technical writing; communication; collaboration skills
Process & Methodology
C&Q Planning, Resource forecasts, Project objectives
Full Job Description
QRC Group, LLC is a firm dedicated to offer services to the Pharmaceutical, Medical Devices and Chemical Industries in the validation and regulatory fields. Log on now to our website http://www.qrcgroup.com / to learn more about our services and solutions! We are seeking a highly motivated Senior Engineer with strong experience in Assembly and Packaging Processes to support commissioning, qualification, and characterization activities within a regulated manufacturing environment. Key Responsibilities 1. Commissioning & Qualification (C&Q) Strategy and Planning * Develop and implement overall C&Q strategies aligned with project objectives and regulatory requirements. * Define system boundaries and identify direct and indirect impact systems. * Lead risk assessments using methodologies such as ISPE Baseline and ASTM E2500. * Develop C&Q plans, schedules, and resource forecasts. 2. Commissioning Activities * Lead and/or execute commissioning activities including FAT, SAT, and field commissioning. * Ensure systems are installed and operating according to design specifications. * Coordinate startup activities with vendors and contractors. * Review and approve commissioning documentation and test results. 3. Qualification Execution (IQ/OQ/PQ) * Author, review, and approve IQ, OQ, and PQ protocols. * Ensure traceability from User Requirements Specifications (URS) through testing activities. * Execute or oversee protocol execution and ensure accurate documentation of results. 4. Documentation & Compliance * Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal standards. * Maintain document lifecycle management within electronic systems. * Support data integrity and ALCOA+ principles throughout qualification activities. * Prepare and support validation summary reports. 5. Risk Management & Change Control * Lead and document risk assessments related to system qualification. * Evaluate and manage change controls impacting validated systems. * Assess deviation
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