Top 2 Biomedical engineer Jobs in Korea Pr

Senior Process Engineer
BioPharma Consulting JAD Group —Juncos, PR
- Contract
- Spanish
- Doctoral degree
- Engineering
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Product Development Engineer
CIS International LLC —Municipio de Juncos, PR
- Full-time
- Spanish
- English
- Mid-level
Quick Apply

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Senior Process Engineer

BioPharma Consulting JAD Group
Juncos, PR

Quick Apply

Job Details

Contract

Qualifications

Incident investigation techniques for hazard identification
Laboratory experiment design
Report preparation
Chemical engineering unit operations
Spanish
Operational analysis
Performance improvement leadership
Project engineering
Content creation for technical audiences
Contractor management
Resource allocation (project management tasks)
Defect resolution root cause analysis
Doctoral degree
Requirements design
Document control experience within pharmaceutical industry
Doctoral degree in engineering
Project change management
Design of manufacturing processes
Engineering
Design of experiments
Technical writing experience within manufacturing
Production deviation management
Production risk assessment
TrackWise
Engineering process optimization
Manufacturing automation
Corrective and preventive actions (CAPA)
English
Project management experience in manufacturing
Trend analysis

Full Job Description

The Senior Engineer independently leads and directs process optimization, troubleshooting, system/facility modifications, and capital project activities within operations, manufacturing, pilot plant, and engineering environments. This role applies advanced engineering principles to design and implement major system changes, experiments, and process improvements.

Key Responsibilities

Execute complex or novel engineering assignments requiring development of new or improved techniques and procedures.
Develop engineering policies and procedures impacting multiple organizational units.
Apply advanced engineering techniques and adapt specialized methods to diverse assignments.
Utilize engineering knowledge beyond core discipline to support cross‑functional initiatives.
Serve as a peer‑recognized SME responsible for determining methodologies in at least one engineering technology area.
Apply mature engineering judgment in planning and conducting projects.
Develop technical solutions to complex problems requiring creativity, innovation, and engineering expertise.
Collaborate with Research, Manufacturing, Process Development, Utilities, Facilities, Quality Assurance, and Validation to define requirements for major system or facility modifications.
Partner with Project Managers to deliver engineering projects within schedule, budget, and quality expectations.
Coordinate external consultants, architects, and engineering firms in developing standard design documentation.
Develop departmental or multi‑disciplinary project budgets and manage cost controls for assigned areas.
Own change controls for manufacturing process changes.
Support major/trend deviation investigations, including root cause analysis, CAPA determination, authoring investigation reports, and presenting during regulatory inspections.
Support risk assessments and microbial evaluation activities.
Design, coordinate, and support execution of functional tests, water tests, and challenge runs for major changes or campaign readiness; generate technical protocols as needed.
Provide guidance during MBR (Master Batch Record) creation and revisions.
Perform assessments supporting process, automation, or equipment modifications and special projects.
Complete assessments for new or modified BOMs (Bill of Materials).

Skills

Working knowledge of pharmaceutical/biotech processes
Familiarity with validation processes and protocol execution
Experience with documentation in highly regulated environments
Ability to operate specialized laboratory and engineering equipment
Ability to interpret and apply GLP, GMP, GDP
Ability to apply engineering science to production systems
Ability to develop solutions to technical problems of limited to moderate scope
Strong problem‑solving and applied engineering skills
Technical report writing and verbal communication skills
Understanding of validation requirements for new equipment installations
Ability to manage multiple projects simultaneously
Ability to determine when internal or external resources are required
Collaboration, facilitation, schedule development, and project management skills
Ability to delegate and manage project work of others
Working knowledge of financial analysis tools
Leadership, conflict resolution, negotiation, and vendor/contractor management

Requirements

Required Education

Doctorate in Engineering, OR
Master’s degree + 2 years of engineering experience, OR
Bachelor’s degree in Engineering + 4 years of engineering experience

Preferred Qualifications

In‑depth experience with bio‑processing unit operations
Knowledge of Root Cause Analysis methodologies (Fishbone, Six Boxes, 5 Why’s, Kepner‑Tregoe)
Familiarity with Lean Manufacturing practices
Strong communication and collaboration skills across manufacturing, process development, and quality
Proficiency in GDP within regulated environments
Experience with systems such as TrackWise, Spotfire, CDOCS, and process monitoring platforms
Strong technical writing and presentation skills
Excellent written and verbal communication skills in English and Spanish

Benefits

6-month contract with possible extension
Adminsitrative shift

Quick Apply

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