Sr. Engineer

QRC Group, LLC•Juncos, PR

About The Position

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.

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.

Nice To Haves

Strong experience in Assembly and Packaging Processes

Responsibilities

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.
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.
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.
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.
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).
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.
Develop characterization protocols.
Execute characterization activities.
Develop and review characterization reports.