Operations & Validation Engineer - GMP & Quality

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 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.