Sr Engineer - 35771

Mirus Consulting Group

🇵🇷 Puerto Rico

Senior

1 week ago

GMP
Regulatory Compliance
Technical Writing
ASTM

1 week 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 motivated Sr. Engineer to provide technical leadership and engineering support for packaging systems and final product manufacturing operations within a regulated pharmaceutical/biotechnology environment. The selected candidate will be responsible for evaluating, qualifying, and supporting primary and secondary packaging materials and components, ensuring compliance with quality, regulatory, and operational requirements. This role requires strong technical expertise in packaging engineering, testing methodologies, project management, and GMP-regulated manufacturing processes.

Key Responsibilities

Provide engineering support for packaging components, systems, and processes used in final product manufacturing operations.
General packagingandengineering experience supporting final product manufacturing operations within the Pharmaceutical or Biotechnology industry.
Lead technical evaluations and studies to support the selection, qualification, implementation, and lifecycle management of packaging materials.
Develop, execute, and approve engineering protocols, test plans, and technical reports to demonstrate packaging system performance and compliance.
Support packaging validation and qualification activities, including transportation and distribution testing.
Evaluate packaging materials and components to ensure compatibility, functionality, product protection, and regulatory compliance.
Analyze test data and generate recommendations to support technical decisions andcontinuous improvement initiatives.
In-depth knowledge of pharmaceuticalprimary and secondary packaging materials and components, including: Bottles, Labels, Trays, Lidding materials, Leaflets, Paperboard packaging, Sterile barrier packaging systems and Corrugated shipping materials.
Strongtechnical writing skills, including protocol development, testing documentation, technical evaluations, and final reports.
Collaborate with Quality, Manufacturing, Supply Chain, Regulatory Affairs, and external suppliers to resolve packaging-related issues.
Investigate technical deviations, non-conformances, and packaging failures, implementing effective corrective and preventive actions when required.
Ensure compliance withGMP, GDP, corporate procedures, and applicable industry standards.
Manage multiple projects simultaneously while maintaining timelines, quality expectations, and business objectives.
Support change control activities related to packaging materials, components, equipment, and processes.
Participate in risk assessments and technical reviews to ensure packaging robustness throughout the product lifecycle.
Familiarity withASTM D4169 and relatedASTM, ISO, TAPPI, USP,andEP testing standards.

Qualifications

Doctorate degree in Engineering, OR
Master’s degree in Engineering and two (2) years of engineering experience, OR
Bachelor’s degree in Engineering and four (4) years of engineering experience.

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 - 35771 · Mirus Consulting Group

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