Specialist Manufacturing

mîrus Consulting Group View all jobs

Juncos, PR
Permanent
Full-time

8 days ago

mîrus Consulting Group is a Puerto Rico based technical services firm headquartered in Humacao. The company specializes in Computer System Validation (CSV) and Information Technology consulting for the pharmaceutical and life sciences industries across Puerto Rico and parts of the United States. Its services include the assessment and validation of automation systems, network infrastructures, and business processes, as well as comprehensive project management support to ensure compliance, efficiency, and operational excellence.Position Summary
The Manufacturing Specialist is responsible for supporting day‑to‑day manufacturing operations in a GMP‑regulated environment. This role ensures manufacturing processes are executed in compliance with established procedures, regulatory requirements, and quality standards. The Manufacturing Specialist plays a key role in deviation documentation, change control execution, and continuous improvement initiatives while supporting operational efficiency and compliance.Key Responsibilities

Support daily manufacturing operations within a pharmaceutical GMP environment, ensuring adherence to batch records, standard operating procedures (SOPs), and safety requirements.
Lead and support deviation documentation, investigation, and resolution in alignment with site procedures and quality standards.
Manage and execute Change Control activities, including assessment, documentation, impact analysis, and implementation.
Collaborate cross‑functionally with Quality, Engineering, Validation, and Supply Chain to resolve operational issues and support process improvements.
Participate in continuous improvement initiatives to enhance process efficiency, compliance, and operational robustness.
Support audits and regulatory inspections by providing documentation, data, and subject matter expertise.

Required Education & Experience
Candidates must meet one of the following education and experience requirements:

Doctorate degree OR
Master’s degree plus 2 years of Manufacturing Operations experience OR
Bachelor’s degree plus 4 years of Manufacturing Operations 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.

mîrus Consulting Group

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