Top 191 Regulatory specialist Jobs in Guaynabo, Pr

Sr. Engineer
PRPDG —Juncos, PR
- $45 - $50 an hour
- Full-time
- Spanish
- Doctoral degree
- 5 years
Quick Apply
Doctor
Puerto Rico Case Management Corp. —Guaynabo, PR
- $55 an hour
- Full-time
- HIPAA
- Outpatient experience
- Neurology
- Paid time off
- Flexible schedule
Quick Apply
Specialist Manufacturing
Weil Group, Inc —Juncos, PR
- Temporary
- Doctoral degree
- Mid-level
- Master's degree
Quick Apply
Senior Parenteral Inspection Technology Specialist
Weil Group, Inc —Manatí, PR
- Temporary
- Background check
- Master's degree
- 8 years
Quick Apply
Especialista De Calidad Clinica
MCS HEALTHCARE HOLDINGS, LLC —San Juan, PR
- Nursing
- RN License
- Bachelor of Science
Compliance Associate
Advantage Life Insurance —San Juan, PR
- Full-time
- Microsoft Word
- English
- Mid-level
Quick Apply
Jr. Validation Specialist
Validation & Engineering Group, Inc —Carolina, PR
- Full-time
- Engineering
- Organizational skills
- 1 year
Quick Apply
EHS Specialist (Multi-site visits)
Mentor Technical Group —Caguas, PR
- Full-time
- Engineering
- 8 years
- Ability to lift 50 pounds
Assistant Applications Specialist
Bio-Nuclear of Puerto Rico —San Juan, PR
- Extended hours
- Communication skills
Quick Apply
EHHS Specialist
US JLP-Jones Lang LaSalle Puerto Rico —Gurabo, PR
- Online Application
- 3 years
- Master's degree
- Bachelor's degree
- Paid parental leave
- Paid holidays
Quick Apply
4d
QA Specialist
US JLP-Jones Lang LaSalle Puerto Rico —Gurabo, PR
- Online Application
- Spanish
- Oracle
- English
- Paid parental leave
- Paid holidays
Quick Apply
4d
Automation Specialist
UPTURN —San Juan, PR
- $60,000 - $100,000 a month
- Extended hours
- Microsoft Word
- Spanish
- Microsoft Excel
Quick Apply
EHS SPECIALIST
MENTOR TECHNICAL GROUP CORP —Dorado, PR
- Engineering
- Mid-level
- Ability to lift 50 pounds
Quick Apply
Specialist QA
BioPharma Consulting JAD Group —Juncos, PR
- Contract
- Doctoral degree
- Computer Science
- Word processing
Quick Apply
Quality Assurance Specialist
PHARMALOGIC HOLDINGS —San Juan, PR
- 8 hour shift
- Bachelor of Science
- Data analysis skills
- Mid-level
- Disability insurance
- Health insurance
Quick Apply
Supervisor(a) Del Programa De Planes De Necesidades Especiales
MCS HEALTHCARE HOLDINGS, LLC —San Juan, PR
- Weekends as needed
- Spanish
- Nursing
- RN License
9d
Photo Specialist
Walgreens —Gurabo Municipio, PR
- $15.00 - $17.50 an hour
- Weekends as needed
- English
- Fair chance
- Entry level
Specialist Quality Assurance
InnovaWorkforce Inc. —Juncos, PR
- $40 - $42 an hour
- 8 hour shift
- Doctoral degree
- Word processing
- Master's degree
Quick Apply
Técnico De Querellas y Apelaciones
MCS HEALTHCARE HOLDINGS, LLC —San Juan, PR
- Spanish
- English
- Research
Medical Data Entry Specialist
PanOncology Trials —San Juan, PR
- Full-time
- Spanish
- English
- Administrative experience
- Health insurance
- Dental insurance
Quick Apply

I want to receive the latest job alert for regulatory specialist in guaynabo, pr

By signing in to your account, you agree to SimplyHired's Terms of Service and consent to our Cookie and Privacy Policy.

Explore jobs in more locations

regulatory specialist jobs near guaynabo, pr

Sr. Engineer

PRPDG
Juncos, PR

Quick Apply

Job Details

Full-time
$45 - $50 an hour

Qualifications

Spanish
Technical engineering
Interpersonal skills
English
Master's degree
Manufacturing facility experience
Bioprocessing
Training & development

Full Job Description

Summary

We are seeking a highly skilled and motivated Senior Engineer to support manufacturing operations within a regulated environment. This role will be responsible for providing technical leadership, supporting process improvements, leading investigations, and collaborating cross-functionally to ensure operational excellence, process robustness, and compliance with regulatory requirements.

Responsibilities

Own change controls related to manufacturing process changes
Support major and trend deviation investigations throughout the full lifecycle
Conduct Root Cause Analysis investigations and determine Corrective and Preventive Actions (CAPA)
Author technical investigation reports and support regulatory inspections
Support Risk Assessment exercises and microbial assessment evaluations
Lead commercial campaign readiness activities and collaborate effectively with cross-functional teams
Assist in the development of training materials and provide technical/scientific process training
Provide manufacturing support and troubleshooting on the production floor
Design, coordinate, and support execution of functional tests, water tests, and process challenge runs during major changes or campaign readiness
Generate technical protocols and related documentation as needed
Assist and provide guidance during Master Batch Record (MBR) creation and revisions
Perform assessments supporting process, automation, or equipment modifications and implementation of special projects
Initiate, revise, and approve standard manufacturing procedures while ensuring procedures reflect current operations
Serve as document owner for manufacturing procedures
Assess process performance and analyze operational data to identify and implement process improvement opportunities
Complete CAPA applicability assessments for other plants/sites
Support assessments for new or revised Bills of Materials (BOMs)
Serve as a recognized technical specialist with responsibility for determining methodologies within assigned areas

Qualifications

Doctorate Degree OR Master’s Degree + 2 years of Engineering experience
OR Bachelor’s Degree in Engineering + 4 years of Engineering experience
Educational background in Life Sciences and/or Engineering
In-depth experience in bioprocessing unit operations
Knowledge of Root Cause Analysis methodologies including Fishbone, Six Boxes, 5 Why’s, Kepner-Tregoe
Familiarity with Lean Manufacturing practices
Ability to communicate and collaborate effectively with technical and management teams across manufacturing, process development, and quality organizations
Proficiency in GDP (Good Documentation Practices) within regulated environments
Experience using systems such as: Trackwise, Spotfire, CDOCS, Process monitoring platforms
Strong technical writing and presentation skills
Excellent verbal and written communication skills in both English and Spanish

Job Type: Full-time

Pay: $45.00 - $50.00 per hour

Experience:

Lean Manufacturing practices : 5 years (Preferred)
GDP (Good Documentation Practices: 5 years (Preferred)
Trackwise: 5 years (Preferred)
Spotfire: 5 years (Preferred)
CDOCS: 5 years (Preferred)
Process monitoring platforms : 5 years (Preferred)
technical writing : 5 years (Preferred)
bioprocessing unit operations : 5 years (Preferred)
Root Cause Analysis methodologies : 5 years (Preferred)
Fishbone: 5 years (Preferred)
Six Boxes: 5 years (Preferred)
5 Why’s: 5 years (Preferred)
Kepner-Tregoe : 5 years (Preferred)

Work Location: In person

Quick Apply

Refine Your Search

regulatory specialist jobs in guaynabo, pr

Sr. Engineer

Doctor

Specialist Manufacturing

Senior Parenteral Inspection Technology Specialist

Especialista De Calidad Clinica

Compliance Associate

Jr. Validation Specialist

EHS Specialist (Multi-site visits)

Assistant Applications Specialist

EHHS Specialist

QA Specialist

Automation Specialist

EHS SPECIALIST

Specialist QA

Quality Assurance Specialist

Supervisor(a) Del Programa De Planes De Necesidades Especiales

Photo Specialist

Specialist Quality Assurance

Técnico De Querellas y Apelaciones

Medical Data Entry Specialist

I want to receive the latest job alert for regulatory specialist in guaynabo, pr

Related Searches

Explore jobs in more locations

Job Seeker Tools

Employer Tools

Browse

Stay Connected