Sr Engineer

Education: Doctorate or Masters + 2 years of Engineering experience or Bachelors in Engineering + 4 years of Engineering experience. Attributes (i.e. - preferred qualifications): Position # 1 & # 2 Experience in biotechnology pharmaceutical process support, especially on Drug Substance processes, and GMP pharmaceutical manufacturing systems. Knowledge in SAP, TrackWise, electronic batch records (PAS/X) , and documents management systems (Veeva). Position # 3: -Bachelor’s in engineering & over 4 years of Engineering experience -Mechanical, Electrical, or Industrial Maintenance knowledge and experience with automated and manual inspection equipment operation. Technical knowledge of inspection technologies for parenteral and glass containers Apply sophisticated and diverse engineering principles to the design and implementation of major system modifications, experiments, process and/or projects. Apply standard engineering techniques and procedures to improve equipment reliability and performance Interact and provide direction to technical resources such as Mechanics, Automation Techs and IS teams. Basic knowledge with validation and documentation processes in a highly regulated environment. Protocol Development and execution requirements. Work with other business functions such as research, manufacturing, process development, utilities, facilities, quality assurance and validation departments to support complex systems and/or facilities modifications. Technical writing and verbal communication on English and Spanish Good organization, presentation and change management skills Position # 4:  Manufacturing Equipment ownership at CMMS system (Work orders approval, closing, PM strategy, spare parts' definition/accuracy/updates), reliability and change control assessments and requirements. Collaborate with Engineering Staff to ensure the best maintenance strategy on manufacturing equipment operations. Responsible for enhancing system reliability focusing on equipment availability, downtime reduction and maintenance optimization Develop equipment performance metrics (availability, downtime, etc.) with emphasis on identifying equipment performance improvement opportunities. Lead the implementation of equipment improvements projects SME (Subject Matter Expert) for systems regarding design, maintenance and point of contact during compliance operations. Support equipment troubleshooting within the functional area or in the scope of technical expertise. Support deviation process and define, Implement and own CAPAs associated to equipment within area of expertise Drives Environmental, Health and Safety compliance within the organization Position # 5: 1. 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. 2. 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. 3. 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. 4. 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. 5. 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). 6. 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. 7. Characterization Process Develop the characterization protocols. Execute the characterization activities. Develop and review the characterization reports. Pay: $50.00 - $52.00 per hour Work Location: In person