Engineer at BioPharma Consulting JAD Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

22 Dec, 25

Salary

0.0

Posted On

23 Sep, 25

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Technical Support, Process Optimization, Troubleshooting, GMP Compliance, Collaboration, Data Analysis, Equipment Improvement, EHS Compliance, Problem Solving, Engineering Principles, Validation Protocols, Technical Writing, Communication Skills, Reliability Engineering, Cross-Functional Collaboration, Project Management

Industry

Biotechnology Research

Description

Under general supervision, the Engineer provides technical support to manufacturing operations by applying engineering principles to troubleshoot, optimize, and improve processes and equipment. This role involves implementing process optimization strategies, equipment/system modifications, upgrades, replacements, and troubleshooting activities in a regulated pharmaceutical/biotech environment. The engineer ensures compliance with corporate policies, industry standards, GMP requirements, and regulatory guidelines. This position requires flexibility to support non-standard shifts, including nights and weekends, depending on business needs. Key Responsibilities Provide solutions to a variety of technical problems of moderate scope and complexity. Evaluate, select, and apply standard engineering techniques and principles with limited supervision. Function as a technical expert for process, equipment, and/or systems during troubleshooting and cross-functional discussions. Frequently participate in daily operations to resolve complex issues or ensure schedules are met. Monitor manufacturing processes and equipment performance; identify and recommend corrective actions and process optimizations. Collaborate with Manufacturing, Maintenance, Utilities, Facilities, QA, Validation, and Process Development teams to define requirements and recommend system modifications. Support manufacturing/quality systems such as deviations, CAPAs, equipment qualifications, and process validations. Apply scientific expertise, compliance knowledge, and troubleshooting skills to manufacturing operations. Organize, analyze, and present interpretation of data and results for operational issues or projects. Apply engineering principles to support design and execution of experiments, system modifications, and capital projects. Lead or support the implementation of equipment improvement projects. Act as SME (Subject Matter Expert) for designated systems regarding design, maintenance, and compliance operations. Drive Environmental, Health, and Safety (EHS) compliance within area of responsibility. Support deviation investigations, define and implement CAPAs, and ensure equipment reliability within assigned area. Develop and track equipment performance metrics (availability, downtime, PM effectiveness, etc.), with focus on improvement opportunities. Manage equipment ownership responsibilities in CMMS (approving/closing work orders, PM strategy, spare parts updates, and reliability assessments). Education & Experience Requirements Master’s degree in Engineering OR Bachelor’s degree in Engineering with 2+ years of engineering experience. Educational background in Mechanical, Electrical, and/or Chemical Engineering. Required Skills & Competencies Experience with equipment and/or process troubleshooting in a regulated (pharma/biotech) environment. Knowledge of pharmaceutical/biotech processes, GMP production operations, and regulatory compliance. Strong organizational and technical writing skills. Proficient presentation and communication skills in English and Spanish. Ability to interpret and apply GLPs and GMPs. Strong problem-solving and applied engineering skills. Basic experience in validation protocols, technical reports, and system documentation. Proficiency with computer systems, CMMS, and technical tools. Preferred Qualifications Ownership of manufacturing equipment in CMMS (work orders, PMs, spare parts accuracy, reliability assessments). Experience leading equipment performance improvement initiatives. Familiarity with validation processes and protocol execution requirements. Strong background in equipment reliability engineering and maintenance strategy development. Proven ability to lead cross-functional collaboration on equipment/system improvements. Demonstrated ability to manage change and drive continuous improvement initiatives. Prior experience as SME for equipment/system compliance and design. Ability to generate project cost estimates, schedules, and evaluate vendor quotes. Shift & Work Schedule Non-standard shift support required (including nights and weekends on a 2/3/2 day schedule as per business needs). Must be flexible to support extended hours when required. Administrative shift available

Responsibilities

The Engineer provides technical support to manufacturing operations by troubleshooting, optimizing, and improving processes and equipment. This role involves collaborating with various teams to ensure compliance and drive process improvements in a regulated environment.