Description:

SUMMARY 

Under general supervision, provides characterization of process optimization strategies and/or troubleshooting of operational issues in the operations, manufacturing, pilot plant, or capital projects environment. Applies basic engineering principles to the design and implementation of system modifications, experiments, and/or capital projects. Organizes, analyses and presents interpretation of results for operational issues or engineering projects of minor scope and complexity.

FUNCTIONS

1. Provide solutions to a variety of technical problems of moderate scope and complexity. 2. Under general supervision will evaluate, select, and apply standard engineering techniques and procedures. Assistance given for unusual problems. 3. Perform assignments that have clear and specific objectives and require investigation of limited number of variables. (*)4. Initiate and complete routine technical tasks. Operations Engineering:1. Function as a technical expert to equipment or systems regarding troubleshooting operations. Frequently become actively involved in daily operations when required to meet schedules or to resolve complex problems. (*)2. Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity. (*)3. Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications. (*) Design Engineering:1. Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints. (*) 2. Work with consultants, architects, and engineering firms on development of standard design documents. (*)3. Obtain and critique quotes for equipment modifications or installations. 4. Generate rudimentary project cost estimates and schedules. * Other functions may be assigned

EDUCATION

Master’s degree or bachelor’s degree in engineering & 2 years of Engineering experience

PREFERRED 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. Demonstrated skills in the following areas: o Problem solving and applied engineering. o Basic technical report writing. verbal communication. Comprehensive understanding of validation protocol execution requirements. Demonstrated Skills in the following areas: o Basic technical presentations o Personal Organization o Validation Protocol Writing o Dealing with and managing change o Technical (Equipment Specific) o Analytical Problem Solving o Computer Literacy

What attributes (i.e. - preferred qualifications) would make this candidate stand out?              

• 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