Apply to Sr Engineer - 35333 | Mirus Consulting Group

Apply to Sr Engineer - 35333

mîrus Consulting Group is a local company based in Humacao, Puerto Rico that provides computer system validation and information technology consulting services to pharmaceutical companies and other organizations across the Island and parts of the United States. Its services include the assessment and validation of automation equipment, network infrastructures and business processes, as well as the project management involved.

Position Summary
The Senior Engineer is responsible for leading Commissioning & Qualification (C&Q) activities for packaging systems, ensuring compliance with regulatory requirements and alignment with project objectives. This role provides technical leadership in developing strategies, executing qualification protocols, and supporting cross-functional teams throughout the project lifecycle.

Key Responsibilities

C&Q Strategy & Planning
1. Develop and implement the overall Commissioning & Qualification strategy aligned with project and regulatory requirements.
2. Define system boundaries and classify direct and indirect impact systems.
3. Lead risk assessments (e.g., ISPE Baseline, ASTM E2500) to determine qualification scope.
4. Develop C&Q plans, timelines, and resource forecasts.
Commissioning Activities
1. Lead and/or execute commissioning activities, including FAT, SAT, and field commissioning.
2. Ensure systems are installed and operate according to design specifications.
3. Coordinate with vendors, contractors, and project teams during system startup.
4. Review and approve commissioning documentation and testing results.
Qualification Execution (IQ/OQ/PQ)
1. Author, review, and approve qualification protocols (Installation, Operational, and Performance Qualification).
2. Maintain traceability from User Requirements Specifications (URS) through testing execution.
3. Oversee protocol execution and ensure accurate documentation of results.
Documentation & Compliance
1. Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal standards.
2. Manage documentation lifecycle within electronic systems.
3. Apply and enforce data integrity principles (ALCOA+).
4. Prepare and support validation summary reports.
Risk Management & Change Control
1. Lead and document risk assessments related to system qualification.
2. Evaluate and manage change controls impacting validated systems.
3. Assess deviations and implement corrective and preventive actions (CAPA).
Cross-functional Collaboration
1. Collaborate with Engineering, Validation, Quality Assurance (QA), Manufacturing, and Supply Chain teams.
2. Interface with system owners and technical authorities.
3. Provide technical coaching and mentorship to junior engineers.
4. Support project meetings, status updates, and stakeholder communications.
Process Characterization
1. Develop characterization protocols.
2. Execute characterization studies for packaging processes.
3. Prepare and review characterization reports.

Qualifications

Doctorate in Engineering, OR
Master’s degree in Engineering with 2+ years of relevant experience, OR
Bachelor’s degree in Engineering with 4+ years of relevant experience

Preferred Qualifications

Experience in packaging processes within regulated environments (pharmaceutical, biotech, or medical devices).
Strong knowledge of GMP, FDA, EMA regulations, and industry standards.
Familiarity with risk-based validation approaches (ASTM E2500, ISPE).
Excellent technical writing, problem-solving, and communication skills.

This Company is an equal employment opportunity employer. We adhere to a policy of making employment decisions without regard to race, color, religion, sex, sexual orientation, national origin, citizenship, age or disability. We assure you that your opportunity for employment with this Company depends solely on your qualifications.