Engineer

Weil Group•Juncos, PR

17d

About The Position

This vital role you will provide technical engineering support to continuous daily operations by performing troubleshooting activities, process optimization strategies, upgrades, replacements, and modifications to the process or equipment in the manufacturing operations. Ensure that all operations are accomplished in a compliant manner consistent with current corporate policies, industry standards, and applicable regulatory requirements. This role will support non-standard shift manufacturing operations that may nights and weekends. Specific responsibilities include but are not limited to: Provide solutions to a variety of technical problems of moderate scope and complexity. Under general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures. Assistance given for unusual problems. Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions. Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems. Routinely supervise manufacturing processes for performance indicators and operations. Suggest problem resolution and provide troubleshooting mentorship. Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for process and/or system modifications. Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions. Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations. Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity. Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects. Support 7/24 non-standard shift operation including extended hours and weekends as per business needs. 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, analyzes 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

Requirements

Masters degree OR Bachelors degree in Engineering & 2 years of Engineering experience
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.

Nice To Haves

Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes
Familiarity with documentation in a highly regulated environment

Responsibilities

Provide solutions to a variety of technical problems of moderate scope and complexity.
Under general supervision will evaluate, select and apply standard engineering techniques, basic principles and procedures.
Function as a technical expert to process, equipment and/or systems during troubleshooting operations and multi-functional discussions.
Frequently become actively involved in daily operations when required to meet schedules or to resolve sophisticated problems.
Routinely supervise manufacturing processes for performance indicators and operations.
Suggest problem resolution and provide troubleshooting mentorship.
Work with manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for process and/or system modifications.
Support the execution of manufacturing/quality systems such as deviations, equipment qualification and/or process validation, procedures, training, and new product introductions.
Apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to support manufacturing operations.
Organizes, analyzes and presents interpretation of results for operational issues or engineering projects of moderate scope and complexity.
Apply basic engineering principles to the design and implementation of system modifications, experiments and/or capital projects.
Support 7/24 non-standard shift operation including extended hours and weekends as per business needs.
Routinely audit the operational performance and regulatory compliance of a moderate number of equipment items or systems of significant complexity.
Work with research, manufacturing, maintenance, process development, utilities, facilities, quality assurance and/or validation departments in developing requirements and recommendations for system modifications.
Work under the direct supervision of project managers to complete design, engineering, and construction projects within schedule and budget constraints.
Work with consultants, architects and engineering firms on development of standard design documents.
Obtain and critique quotes for equipment modifications or installations.
Generate rudimentary project cost estimates and schedules.