Apply to Specialist Manufacturing - 35466

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 Specialist Manufacturing is responsible for supporting manufacturing operations with a strong focus on biotechnology pharmaceutical processes. This role ensures compliance with GMP standards while driving efficiency, reliability, and continuous improvement in Drug Substance manufacturing.

Key Responsibilities

Provide technical support for manufacturing operations, with emphasis on Drug Substance processes
Serve as Deviation Owner for major deviations, leading investigations, performing root cause analysis, and ensuring timely closure with effective CAPA implementation while maintaining full GMP compliance.
Ensure compliance with GMP pharmaceutical manufacturing systems and regulatory requirements
Support troubleshooting and resolution of process and equipment issues
Collaborate with cross-functional teams including Quality, Engineering, and Supply Chain
Manage and maintain accurate documentation using electronic systems
Utilize systems such as SAP, TrackWise, PAS/X (electronic batch records), and Veeva for operations and documentation control
Participate in continuous improvement initiatives to optimize manufacturing performance
Assist in deviation investigations, CAPA implementation, and process validation activities

Qualifications

Doctorate degree OR
Master’s degree + 2 years of Manufacturing Operations experience OR
Bachelor’s degree + 4 years of Manufacturing Operations experience OR
Experience in biotechnology/pharmaceutical manufacturing, particularly Drug Substance processes
Strong knowledge of GMP regulations and manufacturing environment
Hands-on experience with:
- SAP
- TrackWise
- PAS/X (electronic batch records)
- Veeva document management systems
Strong analytical, problem-solving, and communication skills
Ability to work in a fast-paced, regulated environment

Key Competencies

Attention to detail and compliance mindset
Strong technical and operational understanding
Team collaboration and communication
Continuous improvement and problem-solving orientation

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.

Apply to Specialist Manufacturing - 35466

Serve as Deviation Owner for major deviations, leading investigations, performing root cause analysis, and ensuring timely closure with effective CAPA implementation while maintaining full GMP compliance.