Engineer - Manufacturing & Process Support

BioPharma Consulting JAD Group

About The Position

Under general supervision, the Engineer provides technical support for process optimization, troubleshooting, and system improvements across operations, manufacturing, pilot plant, and capital project environments. The role applies basic engineering principles to design and implement system modifications, experiments, and small‑scope capital projects. The Engineer organizes, analyzes, and presents results for operational issues or engineering projects of moderate scope and complexity. This position supports daily operations, including non‑standard shifts, nights, and weekends as required.

Requirements

Master’s degree OR Bachelor’s degree in Engineering + 2 years of engineering experience
Working knowledge of pharmaceutical/biotech processes.
Familiarity with validation processes and documentation in regulated environments.
Ability to operate specialized laboratory equipment and computer systems.
Ability to interpret and apply GLPs, GMPs, and engineering science to production.
Ability to develop solutions to routine technical problems of limited scope.
Understanding of validation protocol execution requirements.
Problem solving and applied engineering.
Analytical problem solving and data interpretation.
Ability to evaluate system performance and recommend improvements.
Computer literacy and equipment‑specific technical skills.
Strong verbal communication skills.
Basic technical report writing and presentation skills.
Ability to organize, analyze, and present technical results clearly.
Personal organization and ability to manage change.
Ability to work independently and collaborate across functions.
Ability to follow complex instructions and complete assignments accurately.

Nice To Haves

Educational background in Mechanical, Electrical, Industrial, or Chemical Engineering.
Experience with equipment and/or process troubleshooting in a regulated environment.
Knowledge of pharmaceutical/biotech processes and GMP production operations.
Strong organizational and technical writing skills.
Proficient communication and presentation skills in English and Spanish.

Responsibilities

Provide solutions to a variety of technical problems of moderate scope and complexity.
Evaluate, select, and apply standard engineering techniques and procedures under general supervision.
Function as a technical expert for process, equipment, and/or systems during troubleshooting activities.
Actively support daily operations to meet production schedules or resolve complex issues.
Monitor manufacturing processes for performance indicators and operational trends; recommend and implement corrective actions.
Apply engineering principles to design and implement system modifications, experiments, and small capital projects.
Work with Manufacturing, Maintenance, Process Development, Utilities, Facilities, Quality Assurance, and Validation to develop requirements and recommendations for process or system improvements.
Support process optimization strategies, upgrades, replacements, and modifications to equipment or processes.
Support execution of deviations, equipment qualification, process validation, procedures, training, and new product introductions.
Assist in generating validation protocols, reports, and data analysis.
Support documentation updates to ensure procedures reflect current operations.
Assist in developing training materials and delivering technical training.
Work under the direction of project managers to complete design, engineering, and construction tasks within schedule and budget.
Collaborate with consultants, architects, and engineering firms on standard design documentation.
Obtain and evaluate quotes for equipment modifications or installations.
Generate basic project cost estimates and schedules.
Perform assignments with clear objectives and limited variables.
Initiate and complete routine technical tasks.
Support 24/7 non‑standard shift operations, including extended hours and weekends as business needs require.
Perform additional duties as assigned.