Sr Engineer - 35600

Mirus Consulting Group

🇵🇷 Puerto Rico

Senior

1 month ago

Regulatory Compliance
calibration
Technical Writing

1 month ago

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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
We are seeking a highly motivatedSenior Engineer to provide technical expertise and leadership in support of equipment assessments and engineering evaluations within a regulated pharmaceutical or biotechnology manufacturing environment. This role is responsible for conducting comprehensive technical assessments, evaluating equipment performance and reliability, supporting quality systems activities, and ensuring equipment remains fit for its intended use while maintaining compliance with cGMP requirements.

Key Responsibilities

Performtechnical assessments of manufacturing equipment to evaluate performance, reliability, operational suitability, and continued fitness for intended use.
Prepare, review, and approvetechnical reports, engineering assessments, equipment evaluations, technical justifications, and supporting documentation.
Evaluateequipment failures, recurring performance issues, maintenance history, operating conditions, and their potential impact on product quality, process performance, equipment qualified state, and regulatory compliance.
Provide engineering support fordeviations, investigations, Corrective and Preventive Actions(CAPAs),change controls, risk assessments, and post-FDA commitment activities.
Assess equipmentdesign, functionality,lifecycle documentation, maintenance strategies, and long-term reliability to support informed technical decision-making.
Review and interpret engineeringdrawings, technical specifications, vendor documentation, equipment manuals, work orders, calibration records, maintenance records, and historical performance data.
Develop scientifically sound, data-drivenconclusions and recommendations supported by objective evidence and documented rationale.
Collaborate effectively with Manufacturing, Maintenance, Automation, Validation, Quality Assurance, Process Development, and external vendors to gather, analyze, and evaluate technical information.
Ensuretechnical assessments are complete, traceable, inspection-ready, and compliant with applicable regulatory and internal quality requirements.
Supportcontinuous improvement initiatives to enhance equipment reliability, operational performance, and compliance.
Maintain a strong field presence by inspecting equipment, verifying actual operating conditions, and confirming technical observations within manufacturing areas.
Independently manage multiple assessments, priorities, and deliverables while meeting project timelines and quality expectations.
Experience supporting purification, fermentation, process equipment, utilities, or pharmaceutical manufacturing systems is preferred.

Qualifications

Bachelor's Degree in Engineering or related technical discipline.
- Minimum of 4 years of engineering experience in the pharmaceutical, biotechnology, or other regulated manufacturing industry.
Experience performingtechnical assessments of manufacturing equipment in a regulated environment.
Strong understanding ofcGMP regulations and quality system requirements.
Excellenttechnical writing, communication, and problem-solving 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.

Sr Engineer - 35600 · Mirus Consulting Group

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