Senior Process Engineer

BioPharma Consulting JAD Group; Juncos (PR); On-site; USD 90,000 - 150,000; Part time

Job summary

BioPharma Consulting JAD Group is seeking a Senior Engineer to independently lead process optimization, troubleshooting, and capital project activities across operations and engineering environments. The role applies advanced engineering principles to design and implement major system changes, experiments, and process improvements.

Responsibilities include developing validation-ready documentation, supporting regulatory inspections, and coordinating cross-functional activities with

Qualifications

• Pharma/biotech process knowledge required.
• Experience with validation protocols and GMP/GLP/GDP.
• Extensive documentation in regulated environments.

Responsibilities

• Lead complex process optimization, troubleshooting, and capital projects.
• Develop and implement design documentation and standard change controls.
• Coordinate with multiple functions to define requirements for major system modifications.
• Support regulatory inspections with investigations and CAPA.
• Manage project budgets and external vendors to meet schedule and quality goals.

Skills

Pharma processes

Validation

Documentation

GMP/GLP/GDP

Engineering analysis

Project management

Root cause analysis

Budgeting

Team leadership

Vendor management

Cross-functional collaboration

Education

Doctorate in Engineering

Master’s + 2 years engineering

Bachelor’s in Engineering + 4 years

Tools

TrackWise

Spotfire

CDOCS

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

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

Contract Details

• 6-month contract with possible extension
• Adminstrative shift