JT771 - SR ENGINEER

QUALITY CONSULTING GROUP, a leader in the pharmaceutical, biotech, medical devices, and manufacturing industry, is looking for a talented, highly motivated and enthusiastic to join our team. In this role, you’ll work with a highly enthusiastic team, contributing in a world-class manufacturing industry in Puerto Rico & USA.

Responsibilities:

• Independently provides and/or directs the characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant or capital projects environment
• Applies advanced and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or capital projects. Develops, organizes, analyzes and presents interpretation of results for operational issues or engineering projects of significant scope and complexity
• C&Q Strategy & Planning
• Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements
• Define system boundaries and identify direct/indirect impact systems
• Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope
• Develop C&Q plans, schedules, and resource forecasting
• Commissioning Activities
• Oversee and/or execute commissioning activities including FAT, SAT, and field commissioning
• Ensure systems are installed and operate per design specifications
• Coordinate with vendors and contractors during startup activities
• Review and approve commissioning documentation and test results
• Qualification Execution (IQ/OQ/PQ)
• Author, review, and approve qualification protocols (IQ, OQ, PQ)
• Ensure traceability from User Requirements Specifications (URS) through testing
• Execute or oversee protocol execution and ensure proper documentation of results
• Documentation & Compliance
• Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards
• Maintain document lifecycle within electronic systems
• Support data integrity and ALCOA+ principles throughout qualification activities
• Prepare and support validation summary reports
• Risk Management & Change Control
• Lead and document risk assessments related to system qualification
• Evaluate and manage change controls impacting validated systems
• Assess impact of deviations and implement corrective and preventive actions (CAPA)
• Cross-functional Coordination
• Collaborate 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 communication
• Characterization Process
• Develop the characterization protocols
• Execute the characterization activities
• Develop and review the characterization reports

Qualifications:

• Bachelor's degree in Engineering, Packaging Engineering, or a related technical field.
• Experience in packaging and/or engineering within final product manufacturing in the pharmaceutical or biotechnology industry
• Strong knowledge of Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP)
• Knowledge of pharmaceutical primary and secondary packaging materials, including bottles, labels, trays, lidding materials, leaflets, paperboard, sterile barrier packaging, corrugated materials, and related packaging components
• Familiarity with distribution testing standards, including ASTM D4169, ASTM, ISO, TAPPI, USP, and EP.
• Strong project management, technical problem-solving, interpersonal, and written/verbal communication skills
• Ability to work effectively in a cross-functional team environment and adapt to changing business priorities
• Experience writing test protocols, conducting technical evaluations, and performing packaging or material testing to support technical reports and material/component qualification