Title: Senior Engineer (3606404)
Location: Juncos, Puerto Rico
Schedule: Hybrid | Administrative Shift
Contract Duration: 5 Months
Eligibility: Open to Puerto Rico Residents
Position Summary
We are seeking an experienced and highly motivated Senior Engineer to support manufacturing operations, process optimization, troubleshooting activities, and capital projects within a regulated pharmaceutical manufacturing environment. This role requires strong technical expertise, problem-solving capabilities, and the ability to lead complex engineering initiatives independently while collaborating with cross-functional teams.
The selected candidate will support process improvements, deviation investigations, change controls, risk assessments, validation activities, and manufacturing readiness initiatives while ensuring compliance with GMP and regulatory requirements.
Key Responsibilities
- Own and manage change controls related to manufacturing process changes.
- Lead and support deviation investigations throughout the full lifecycle, including:
- Root Cause Analysis (RCA)
- Corrective and Preventive Actions (CAPA)
- Investigation reports
- Regulatory inspection support
- Support risk assessments and microbial assessment evaluations.
- Lead commercial campaign readiness activities and coordinate cross-functional support.
- Provide floor support and troubleshooting for manufacturing operations.
- Design, coordinate, and execute functional tests, water tests, and process challenge runs.
- Generate and execute technical protocols and engineering documentation.
- Support Master Batch Record (MBR) creation and revisions.
- Assess process, automation, and equipment modifications for special projects and process improvements.
- Initiate, revise, review, and approve manufacturing procedures and technical documentation.
- Analyze process performance data and implement process optimization initiatives.
- Support CAPA applicability assessments across manufacturing sites.
- Evaluate and assess changes related to Bills of Materials (BOMs).
- Collaborate with Manufacturing, Process Development, Quality, Validation, Utilities, and Engineering teams.
- Support validation activities and ensure compliance with GMP and GDP practices.
- Present technical information and investigation outcomes during audits and inspections.
Preferred Qualifications
- Bachelor’s Degree in Engineering with 4+ years of engineering experience OR
- Master’s Degree with 2+ years of engineering experience OR
- Doctorate Degree
Preferred Technical Experience
- Pharmaceutical or biotechnology manufacturing environments
- Bio-processing unit operations
- Process optimization and troubleshooting
- Validation processes and protocol execution
- Root Cause Analysis methodologies:
- Fishbone
- 5 Whys
- Kepner-Tregoe
- Six Boxes
- Lean Manufacturing principles
- GMP and GDP documentation practices
- Process monitoring and data analysis
- Change control and CAPA systems
Preferred Systems Knowledge
- TrackWise
- Spotfire
- CDOCS
- Process monitoring platforms
Required Skills & Competencies
- Strong analytical and engineering problem-solving skills
- Technical writing and presentation skills
- Ability to manage multiple projects simultaneously
- Experience in highly regulated GMP environments
- Effective communication in English and Spanish
- Strong collaboration and leadership skills
- Ability to work independently with minimal supervision
- Experience supporting cross-functional manufacturing operations
- Knowledge of validation processes and documentation requirements
- Ability to develop technical solutions for complex engineering problems
- Project coordination and schedule management experience
Additional Competencies
- Conflict resolution and negotiation
- Leadership and team development
- Contractor and vendor management
- Budget and project cost awareness
- Facilitation and collaboration skills
- Technical report writing
- Process improvement mindset
- Computer literacy and engineering systems knowledge