Engineer

Echo-Consulting-Group; Puerto Rico; On-site; USD 55,000 - 75,000; Full time

Job summary

ECHO Consulting Group is a leader in quality and regulatory solutions for pharma, biotech, and related industries. We seek an Operations/Design Engineer to optimize processes and troubleshoot issues in manufacturing, pilot plants, and capital projects.

Under supervision, you will apply engineering principles to design modifications, prepare cost estimates, and collaborate with multiple departments to meet project goals.

Qualifications

• Master’s or Bachelor’s degree in Engineering with 2 years of engineering experience.
• GDP knowledge is preferred for regulated environments.
• Experience with change control processes and risk assessments.
• Knowledge of commissioning and decommissioning activities.
• Understanding asset lifecycle management.
• Ability to coordinate cross-functional teams and stakeholders.
• Experience managing technical documentation and records.
• Capability to execute impact assessments and support regulatory compliance.
• Strong organizational, planning, and project management skills.
• Excellent written and verbal communication skills.
• Ability to manage multiple priorities and meet project deadlines.
• Technical troubleshooting and problem-solving skills.
• Experience driving continuous improvement initiatives.
• Self-motivated, detail-oriented, and proactive approach to work.
• Ability to collaborate effectively with Engineering, Operations, Maintenance, Quality, and Validation teams.

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.
• 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.
• Routinely audit the operational performance and regulatory compliance of equipment/items.
• Work with cross-functional teams in developing requirements for system modifications.
• Work under the direct supervision of project managers to complete design, engineering, and construction projects.
• Obtain and critique quotes for equipment modifications or installations.
• Generate rudimentary project cost estimates and schedules.
• Other functions may be assigned

Skills

Problem solving

Engineering fundamentals

Technical communication

Analytical thinking

Validation protocol writing

Document control

Education

Bachelor's or Master's in Engineering

Job description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

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.

Operations Engineering:

• 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.

Design Engineering:

• 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

Shift: 1st Shift

Location: Juncos, PR

Education:

Master’s degree OR Bachelor’s degree in Engineering & 2 years of Engineering experience.

Preferred Qualifications:

• Experience supporting equipment and system decommissioning projects in a regulated manufacturing environment.

• Strong knowledge of Good Documentation Practices (GDP).

• Experience with change control processes and risk assessments.

• Knowledge of commissioning and decommissioning activities.

• Understanding of asset lifecycle management.

• Ability to coordinate cross-functional teams and stakeholders.

• Experience managing technical documentation and records.

• Capability to execute impact assessments and support regulatory compliance.

• Strong organizational, planning, and project management skills.

• Excellent written and verbal communication skills.

• Ability to manage multiple priorities and meet project deadlines.

• Technical troubleshooting and problem-solving skills.

• Experience driving continuous improvement initiatives.

• Self-motivated, detail-oriented, and proactive approach to work.

• Ability to collaborate effectively with Engineering, Operations, Maintenance, Quality, and Validation teams.

Skills:

• Problem-solving and applied engineering.

• Basic technical report writing. Verbal communication. Comprehensive understanding of validation protocol execution requirements.

• Basic technical presentations

• Personal Organization o Validation Protocol Writing

• Dealing with and managing change

• Technical (Equipment Specific)

• Analytical Problem Solving

• Computer Literacy

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.