Company 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!
Job Description
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 deviations and implement corrective and preventive actions (CAPA).
6. Cross-Functional Collaboration
-
Partner with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.
-
Interface with system owners and technical authorities.
-
Provide technical guidance and mentorship to junior engineers and project team members.
-
Support project meetings, status reporting, and stakeholder communications.
7. Process Characterization
-
Develop characterization protocols.
-
Execute characterization activities.
-
Develop and review characterization reports.
Qualifications
Requirements
-
Doctorate degree, or Master’s degree with 2+ years of experience, or
Bachelor’s degree in Engineering with 4+ years of experience. -
Experience in GMP-regulated manufacturing environments.
-
Strong 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.
Additional Information
All your information will be kept confidential according to EEO guidelines.
