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:- Experience in biotechnology pharmaceutical process support, especially on Drug Substance processes.
- GMP pharmaceutical manufacturing systems.
- Knowledge in SAP, TrackWise, electronic batch records (PAS/X), and documents management systems (Veeva).
- Familiarity with validation processes in a highly regulated environment
- Technical writing and verbal communication on English and Spanish.
Responsibilities:- Complete complex or novel assignments requiring development of new and/or improved engineering techniques and procedures.
- Develop engineering policies and procedures that affect multiple organizational units.
- Coordinate and review work of a small staff of engineers, associates and/or technicians on an ongoing basis as well as on a project basis.
- Employ advanced engineering techniques and/or modifications of advanced techniques within area of engineering expertise.
- Apply knowledge of engineering principles and practices outside of area of discipline expertise to broad variety of assignments in related fields.
- Serves as a peer-recognized engineering technology specialist in at least one area, with overall responsibility for determining methodologies in that area.
- Work with project managers to complete design and engineering projects within schedule, budget and quality constraints.
- Coordinate the work of consultants, architects and engineering firms on development of standard design documents.
Education:
- Doctorate OR Masters + 2 years of Engineering experience OR bachelor's in engineering + 4 years of Engineering experience.
