BioPharma Consulting JAD Group

Advises drugmakers on engineering and compliance

Manufacturing Specialist - Process Support and NPI

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timeJuncos, Puerto RicoNo salary listed

About the Job

Requirements

A Bachelor's degree and 4 years of manufacturing operations experience, or a Master's degree and 2 years, an Associate's degree and 8 years, a high school education and 10 years, or a Doctorate.
Hands-on manufacturing floor support experience in a Good Manufacturing Practice (GMP) environment.
Detailed technical understanding of bioprocessing unit operations.
Experience writing and approving manufacturing procedures, nonconformance investigations, and corrective and preventive actions (CAPAs).
Strong technical writing and presentation skills, basic project management skills, and basic control charting.
Bilingual proficiency in English and Spanish.

Responsibilities

Assess process performance by observing floor operations and reviewing performance data, then plan and implement improvements.
Initiate, revise, and approve manufacturing procedures as the document owner, and help build training materials.
Provide process troubleshooting support.
Triage nonconformances, author investigation reports, execute corrective actions, close nonconformances and CAPAs on time, and monitor and communicate trends.
Support process monitoring, including control limits and quarterly reports, and support process validation protocols, execution, and data analysis.
Participate in the new product introduction (NPI) process to assess documentation, materials, training, and equipment modification needs.
Assist the manufacturing change owner on change control review board (CCRB) packages, participate in regulatory inspections, and support special projects.

Desired Qualifications

NPI and change control (CCRB) support experience.

Manufacturing Specialist - Process Support and NPI

BioPharma Consulting JAD Group · Juncos, Puerto Rico · Contract · Posted 2026-11-03

Workplace: on_site

Department: Amgen

Description

Support manufacturing operations from the floor at a leading biotechnology company in Juncos, Puerto Rico. With minimal supervision, you will own procedures, troubleshoot the process, drive nonconformances and CAPAs to closure, and support new product introductions and change control.

What you'll do

Assess process performance by observing floor operations and reviewing performance data; plan and implement improvements.
Initiate, revise and approve manufacturing procedures as document owner; help build training materials.
Provide process troubleshooting support.
Triage nonconformances, author investigation reports, execute corrective actions and close NC/CAPAs on time; monitor and communicate trends.
Support process monitoring (control limits, quarterly reports) and process validation protocols, execution and data analysis.
Participate in the NPI process to assess documentation, materials, training and equipment modification needs.
Assist the manufacturing change owner on CCRB packages; participate in regulatory inspections and special projects.

Requirements

Bachelor's degree + 4 years of manufacturing operations experience (or Master's + 2, Associate's + 8, High School + 10, or a Doctorate).
Hands-on manufacturing floor support experience in a GMP environment.
Detailed technical understanding of bioprocessing unit operations.
Experience writing and approving manufacturing procedures, nonconformance investigations and CAPAs.
NPI and change control (CCRB) support experience is a plus.
Strong technical writing, presentation and basic project management skills; basic control charting.
Bilingual English/Spanish.

Benefits

Contract: 12 months, with possible extension
Shift: Administrative; non-standard shift may be required

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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