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 Senior Engineer with a strong background in Mechanical Engineering and packaging systems to support the design, evaluation, and implementation of primary and secondary packaging solutions in a regulated environment. This role requires deep technical expertise in material science, packaging validation, and distribution testing, along with the ability to lead projects and collaborate across cross-functional teams. The ideal candidate will ensure compliance with global standards and support the selection and qualification of packaging materials used in healthcare products.
Key Responsibilities
Lead engineering activities related to packaging design, development, and qualification for primary and secondary systems.
Material knowledge of structural components is integral in the day-to-day oversight of this role:
Labels
Trays and lidding materials
Sterile barrier systems
Paperboard and corrugate
Leaflets and structural components
Develop, review, and approve engineering drawings using tools such as AutoCAD, SolidWorks, or Adobe Illustrator.
Design and execute distribution testing in accordance with ASTM D4169 and other applicable standards.
Apply knowledge of global standards including:
ISO (International Organization for Standardization)
TAPPI (Technical Association of the Pulp and Paper Industry)
USP / EP (United States Pharmacopoeia/ European Pharmacopoeia)
Author and execute test protocols, perform technical evaluations, and generate reports to support material and packaging validation.
Ensure compliance with Good Manufacturing Practices (GMP) and Good Documentation Practices (GDP).
Lead or support cross-functional project teams, ensuring timely completion of deliverables.
Identify technical issues, perform root cause analysis, and implement effective solutions.
Work independently while contributing to team objectives in a dynamic, fast-paced environment.
Minimum Qualifications One of the following is required:
Doctorate Degree in Engineering, OR
Master’s Degree in Engineering + 2 years of experience, OR
Bachelor’s Degree in Engineering + 4 years of experience
Preferred Qualifications
Degree in Mechanical Engineering (strongly preferred)
Experience in packaging engineering or material science within regulated industries (pharma, medical devices, biotech)
Familiarity with distribution testing standards (ASTM D4169)
Experience working with global regulatory and pharmacopeia standards (USP, EP)
Required Skills & Competencies
Strong knowledge of packaging systems and material science
Experience with engineering design software (AutoCAD, SolidWorks, Adobe Illustrator or equivalent)
Excellent project management and organizational skills
Strong technical problem-solving abilities
Effective written and verbal communication skills
Ability to lead and collaborate within cross-functional teams
Demonstrated ability to manage multiple priorities in evolving environments
Fully bilingual (English/Spanish)
Additional Requirements
Strong understanding of GMP and GDP compliance
Experience in testing, validation, and technical documentation
Ability to lead initiatives and work with minimal supervision
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.