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:- 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
Education:- Doctorate OR Masters + 2 years of Engineering experience OR Bachelor's in engineering + 4 years of Engineering experience.
