BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

Senior Engineer - Multiple Teams

Bioprocess & BiomanufacturingPosted on Nov 11

Full-timeJuncos, Puerto RicoNo salary listed

About the Job

Requirements

A Bachelor's degree in Engineering with four years of experience, a Master's degree with two years of experience, or a Doctorate is required; Chemical, Mechanical, Electrical, Industrial, Biomedical, or a related engineering field is acceptable.
Experience supporting manufacturing in a GxP/GMP environment is required.
Knowledge of change control, controlled documentation, and data integrity is required.
Strong Excel skills are required.
Candidates must be fully bilingual in English and Spanish.

Responsibilities

Lead continuous process verification (CPV) activities, including process data review, trend identification, periodic reporting, and escalation of performance issues.
Configure and support manufacturing systems, including DME, PLM, and MMP/MPP management; gather requirements, implement and test changes, and document results.
Coordinate controlled document and process changes through review, approval, and implementation.
Interpret manufacturing data to support investigations, troubleshooting, and continuous improvement.
Use digital tools to improve reporting, monitoring, and workflows.

Desired Qualifications

Experience with JMP and/or Power BI is a plus.
Experience with SQL, Smartsheet, Power Query, or Power Automate is a plus.

Senior Engineer - Process Monitoring, CPV and Manufacturing Systems

BioPharma Consulting JAD Group · Juncos, Puerto Rico · Contract · Posted 2026-11-11

Workplace: on_site

Department: Amgen

Description

Support manufacturing process engineering, system configuration and continuous process verification for drug product operations at a leading biotechnology company in Juncos, Puerto Rico.

What you'll do

Lead CPV activities: process data review, trend identification, periodic reports and escalation of performance issues.
Configure and support manufacturing systems (DME, PLM, MMP/MPP management): gather requirements, implement and test changes, and document results.
Coordinate controlled document and process changes through review, approval and implementation.
Interpret manufacturing data to support investigations, troubleshooting and continuous improvement.
Use digital tools to improve reporting, monitoring and workflows.

Requirements

Bachelor's in Engineering + 4 years (or Master's + 2, or Doctorate); Chemical, Mechanical, Electrical, Industrial, Biomedical or related.
Manufacturing support in a GxP/GMP environment.
Change control, controlled documentation and data integrity.
Strong Excel; JMP and/or Power BI.
SQL, Smartsheet, Power Query or Power Automate (a plus).
Fully bilingual (English/Spanish).

Benefits

Contract: 7 months, with possible extension
Shift: Administrative, Monday–Friday

Apply

Apply at BioPharma Consulting JAD Group

About the Company

BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

BioPharma Consulting JAD Group advises pharmaceutical and biotechnology businesses on engineering, quality and regulatory compliance. It works with companies operating under US Food and Drug Administration rules to develop technical solutions for their manufacturing plants and processes. Its engineering practice covers facility and equipment design, process improvements and project management, while validation work verifies and documents that production systems meet requirements. The firm sells tailored consulting and technical support for assignments and projects, with company managers involved in delivery. Founded in 2010, it is headquartered in Cambridge, Massachusetts.

Company size: 51-200
Company stage: Not listed
Total funding: Not listed
Headquarters: Cambridge, MA
Founded: 2010

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