IntePros is seeking a highly motivated and detail-oriented Quality Control (QC) Laboratory Project Engineer to support a large capital project. This role will focus on supporting the procurement and coordinating the receipt, installation, commissioning, and qualification of analytical instrumentation and systems within the laboratory environment. The ideal candidate will have hands-on experience with analytical instruments, strong organizational skills, and excellent communication abilities to collaborate effectively with cross-functional teams and vendors.
This position will work under Site Engineering teams and directly with Quality Control, Facilities, Validation, and Metrology. This person will also routinely work with and support project startup, construction, and applicable subcontractors.
Responsibilities
Project Coordination & Instrument Implementation :
- Oversee the planning, day-to-day coordination / execution, and completion of analytical instrument implementation projects in alignment with the broader capital project timeline.
- Develop and maintain project schedules, ensuring timely delivery, installation, commissioning, and qualification of laboratory instrumentation.
- Collaborate with internal stakeholders, including Quality Control, Validation, Engineering, Procurement, Facilities, and Metrology teams to ensure smooth project execution.
- Execute and document infield verification and resolve any discrepancies.
- Maintain and organize trackers for identified discrepancies and issues and drive resolution to ensure minimal impact on project timelines.
Vendor Management & Coordination :
Act as the primary point of contact for all vendors supplying analytical instrumentation, ensuring clear communication of project expectations and timelines.Coordinate vendor activities, including site visits, installation, setup, and operational testing of instruments.Schedule and oversee vendor-led Site Acceptance Testing (SAT) to verify instrument functionality and compliance with specifications.Ensure vendors adhere to site safety, security, and compliance requirements during installation and testing activities.Track vendor deliverables and service contracts to confirm compliance with agreed-upon terms.Compliance, Documentation & Reporting :
Ensure all installations and qualifications are completed in accordance with FDA, USP, ICH, and other applicable regulatory standards.Maintain detailed records of project progress, vendor interactions, qualification protocols, deviations, and corrective actions.Assist in the development and revision of Standard Operating Procedures (SOPs) related to instrument operation, maintenance, and qualification.Provide regular status updates to project teams and leadership, highlighting risks, challenges, and mitigation strategies.Education and Experience Requirements
Bachelor's degree in Engineering, Mechanical, Chemical, Biology, or a related field.5 years of experience working with analytical instruments in a QC laboratory, pharmaceutical, biotechnology, or regulated industry.Direct experience managing projects related to laboratory equipment installation and qualification.Hands-on familiarity with analytical instrumentation, such as HPLC, GC, UV-Vis, TOC, FTIR, dissolution testers, and other lab systems.Experience working with vendors for instrument procurement, installation, and qualification.Knowledge of cGMP, GLP, FDA, and industry best practices for laboratory compliance.Experience with Large Capital Project Execution.Strong attention to detail and problem-solving skills.Ability to work independently and communicate across functions.
