Sr Quality Engineer

Echo-Consulting-Group; Puerto Rico; On-site; USD 60,000 - 90,000; Full time

Job summary

Echo Consulting Group is seeking a seasoned professional in quality assurance and validation for challenging roles in pharmaceutical, biotech and medical device environments. The role emphasizes IQ/OQ/PQ validation, GMP compliance, and cross-functional collaboration to deliver compliant, reliable processes.

The position requires an engineering degree and experience in regulated manufacturing. You will work with Manufacturing, Engineering and QA to ensure quality from design through

Qualifications

• Bachelor's in Engineering or equivalent technical degree.
• Strong expertise in equipment and process validation (IQ/OQ/PQ).
• Knowledge of GMP and regulatory compliance in manufacturing.
• Experience supporting validation documentation and change controls.
• Ability to collaborate across Manufacturing, Engineering and QA teams.

Responsibilities

• Develops, modifies, applies and maintains quality standards.
• Collaborates with engineering and manufacturing to ensure quality standards.
• Develops and implements methods for inspecting, testing and evaluating products and production equipment.
• Performs statistical analysis and ensures documentation is compliant.
• May specialize in design, production control, product evaluation and reliability.

Skills

Quality Assurance

IQ/OQ/PQ

GMP knowledge

Regulatory compliance

Project management

Education

Bachelor'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:

Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education.

Responsibilities:

• Responsibilities may include the following and other duties may be assigned.

• Develops, modifies, applies and maintains quality standards.

• Collaborates with engineering and manufacturing functions to ensure quality standards are in place.

• Develops and implements methods and procedures for inspecting, testing and evaluating products and production equipment.

• Performs statistical analysis. Ensures that documentation is compliant with requirements.

• May specialize in the areas of design, production control, product evaluation and reliability, as they apply to product or process quality.

Shift: 1st shift

Location: Juncos, PR

Education:Bachelor's in Engineering

Preferred Qualifications:

• Strong expertise in equipment and process validation (IQ/OQ/PQ), including requalification for new, modified, or relocated equipment

• Ability to perform risk-based change assessments and define appropriate validation or “no impact” strategies

• Experience supporting equipment purchases, relocations, and decommissioning with full quality and compliance oversight

• Deep understanding of regulated manufacturing environments (QMS, GMP, document control, traceability)

• Proven capability to develop, review, and approve validation protocols, reports, and change control documentation

• Experience ensuring audit‑ready documentation and compliance with internal and regulatory requirements

• Ability to assess and support cleanroom and facility‑related changes, including environmental and process impact

• Strong cross‑functional collaboration with Manufacturing, Engineering, Validation, Facilities, and suppliers to drive execution

• Skilled in risk identification, mitigation planning, and deviation management during validation and implementation activities

• Ability to manage multiple priorities and deliver results in a fast‑paced, high‑change environment

Skills:

• Autonomy: Seasoned individual contributor. Works independently under limited supervision to determine and develop approach to solutions. Coaches and reviews the work of lower level specialists .

• Organizational Impact: May be responsible for entire projects or processes within job area. Contributes to the completion of work group objectives, through building relationships and consensus to reach agreements on assignments.

• Innovation and Complexity: Problems and issues faced are difficult, and may require understanding of multiple issues, job areas or specialties . Makes improvements of processes, systems or products to enhance performance of the job area. Analysis provided is indepth in nature and often provides recommendations on process improvements.

• Communication and Influence: Communicates with senior internal and external customers and vendors. Exchange information of facts, statuses, ideas and issues to achieve objective, and influence decisionmaking. Leadership and Talent Management: May provide guidance, coaching and training to other employees within job area.

• Required Knowledge and Experience: Requires advanced knowledge of job area combining breadth and depth, typically obtained through advanced education combined with experience. May have practical knowledge of project management.

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.