Job Description: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.
Requirements & Qualifications:- Working knowledge of pharmaceutical/biotech processes
- Familiarity with validation processes
- Familiarity with documentation in a highly regulated environment
- Ability to operate specialized laboratory equipment and computers as appropriate.
- Ability to interpret and apply GLPs and GMPs.
- Ability to apply engineering science to production.
- Able to develop solutions to routine technical problems of limited scope
Responsibilities:- 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.
- 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.
- 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.
- 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.
- 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).
- 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.
- Develop the characterization protocols.
- Execute the characterization activities.
- Develop and review the characterization reports
Education:- Doctorate OR -Masters + 2 years of Engineering experience OR -Bachelors in Engineering + 4 years of Engineering experience.
