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
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Position Summary
The
Senior Engineer provides advanced technical leadership in support of manufacturing operations, ensuring process robustness, compliance, and continuous improvement. This role acts as a key contributor in process optimization, deviation management, and cross-functional initiatives, while serving as a subject matter expert in designated technical areas within a regulated environment.
Key Responsibilities
• Own
change controls for manufacturing process changes
• Support major/trend
deviation investigations throughout the whole lifecycle including
Root Cause Analysis investigation, determination of
Corrective/Preventive Actions, authoring process investigation reports, and presenting within regulatory inspections.
• Support
Risk Assessments exercises and
Microbial assessment evaluations.
• Led commercial campaign readiness and effectively communicate and collaborate with cross function areas.
• Assist in the generation of training materials and assist in providing training on scientific or technical aspects of the process.
• Provide commercial support when needed and assist on the floor troubleshooting.
• Design, coordinate, and support execution of functional tests, water tests, and other runs to challenge process and operations during major changes, or campaign readiness. Generate technical protocols as needed.
• Assist and provide guidance during
MBR (Master Batch Record) creation/revisions.
• Perform assessment to support process, automation, or equipment modification or implementation of special projects
• Initiate, revise, and approve standard manufacturing procedures. Ensure all procedures reflect current operations. Serve as a document owner.
• Assess process performance and review of performance data. Evaluate, plan, and implement solutions for process improvement opportunities.
• Complete assessments for
CAPA applicability requests from other plants/sites
• Complete assessment for new or changes in
BOM's (Bill of Materials)
• Serves as a peer-recognized specialist in at least one area, with overall responsibility for determining methodologies in that area.
Minimum Qualifications
- Doctorate Degree, OR
- Master’s Degree with 2 years of Engineering experience, OR
- Bachelor’s Degree in Engineering with 4 years of Engineering experience
- Educational background in Engineering and/or Life Sciences.
- Strong experience in bioprocessing unit operations is preferred.
Preferred Qualifications
- Expertise in Root Cause Analysis tools, including:
- Fishbone Diagram
- 5 Whys
- Kepner-Tregoe
- Six-Box Model
- Knowledge of Lean Manufacturing practices.
- Experience working in regulated environments (GMP) with strong knowledge of Good Documentation Practices (GDP).
- Proficiency with systems such as:
- TrackWise
- Spotfire
- CDOCS
- Process monitoring platforms
- Strong collaboration skills across Manufacturing, Quality, and Process Development.
- Excellent technical writing, presentation, and communication skills.
- Bilingual proficiency in English and Spanish.
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.
