Engineer

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

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 and procedures. Assistance given for unusual problems.; Perform assignments that have clear and specific objectives and require investigation of limited number of variables.; Initiate and complete routine technical tasks.; 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.; 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.; Other functions may be assigned.; 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.; 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.

Requirements

Master’s degree OR Bachelor’s degree in Engineering & 2 years of Engineering experience.; Problem solving and applied engineering.; Basic technical report writing.; Verbal communication.; Comprehensive understanding of validation protocol execution requirements.; Basic technical presentations; Personal Organization; Validation Protocol Writing; Dealing with and managing change; Technical (Equipment Specific); Analytical Problem Solving; Computer Literacy

Nice to have

Experience with equipment and/or process troubleshooting in a regulated environment.; Knowledge of pharmaceutical/biotech processes and GMP production operations.; Organizational & technical writing skills.; Proficient presentation & communication skills in English and Spanish

Benefits

Medical; dental; vision care; support for working families (backup dependent care, adoption assistance, infertility coverage, family building support); behavioral health solutions; paid parental leave; paid caregiver leave; training programs; professional development resources; mentorship programs; employee resource groups; volunteer activities