Sr Process Engineer

Company : Eqval

Job Type : Full Time

Las Piedras, Las Piedras

Number of Applicants

000+

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Job Description - Sr Process Engineer

EQVAL Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others). We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.

We are seeking a Process Validation Engineer with hands-on experience in solid oral dosage manufacturing. The ideal candidate will be responsible for leading the validation and continuous improvement of pharmaceutical manufacturing processes, focusing on granulation, compression, and encapsulation/tableting operations.

Responsabilities:

Lead validation activities for solid dosage manufacturing processes, including wet and dry granulation, blending, compression, and coating.
Author, review, and execute process validation protocols and reports (PPQ, CPV), ensuring alignment with corporate and regulatory requirements.
Collaborate with cross-functional teams (QA, Manufacturing, Engineering, Regulatory Affairs, R&D) to support technology transfers, scale-ups, and process improvements.
Conduct risk assessments (e.g., FMEA) and data analysis to identify and control critical process parameters (CPPs) and critical quality attributes (CQAs).
Support equipment qualification (IQ/OQ/PQ) as it relates to the manufacturing process.
Participate in cleaning validation efforts for shared or dedicated equipment.
Analyze manufacturing data using statistical tools (e.g., Minitab) to ensure process capability and performance.
Investigate deviations or process failures and implement corrective/preventive actions (CAPA).
Support internal and external audits, providing validation documentation and responses as needed.

Minimum Requirements:

Bachelor's Degree in an Engineering
5+ years of knowledge and experience in cGMP in a Pharmaceutical manufacturing environment.
5+ years of Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation for pharmaceutical products.
5+ years of statistical analysis (GR&R) and data management (including the usage of statistical tools, i.e, Minitab).
Knowledge in Computer System Validation (CSV).
Good technical writing skills in English and Spanish.
Project management skills required.
Fully bilingual (English and Spanish).

On-site role – Applicants must currently reside in Puerto Rico

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Sr Process Engineer

Job Description - Sr Process Engineer

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