Senior Engineer (3606404)
Not Disclosed•TemporaryHybrid
location_onHybrid
About the Role
We are seeking an experienced and highly motivated Senior Engineer to join our team in Juncos, Puerto Rico. This position is critical for supporting manufacturing operations, process optimization, and troubleshooting within a regulated pharmaceutical manufacturing environment.
In this role, you will lead complex engineering initiatives independently while collaborating with cross-functional teams. You will be responsible for driving process improvements, managing deviation investigations, and ensuring strict compliance with GMP and regulatory requirements. The ideal candidate will bridge the gap between technical engineering and operational execution, ensuring manufacturing readiness for commercial campaigns and maintaining the highest standards of quality and safety.
Work location
Work model: Hybrid
Hybrid
Key Responsibilities
- check_circleOwn and manage change controls related to manufacturing process changes
- check_circleLead deviation investigations including root cause analysis and CAPA
- check_circleDesign, coordinate, and execute functional tests and process challenge runs
- check_circleGenerate and execute technical protocols and engineering documentation
- check_circleSupport Master Batch Record creation and revisions
- check_circleAnalyze process performance data and implement optimization initiatives
- check_circleProvide floor support and troubleshooting for manufacturing operations
- check_circleCollaborate with cross-functional teams to ensure GMP compliance
Requirements
- verifiedBachelor's Degree in Engineering with 4+ years experience OR Master's Degree with 2+ years experience OR Doctorate Degree
- verifiedOpen to Puerto Rico Residents
- verifiedEffective communication in English and Spanish
Nice to Have
Bachelor's Degree in Engineering with 4+ years of engineering experience, Master's Degree with 2+ years of engineering experience, or Doctorate Degree. Experience in 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. Knowledge of TrackWise, Spotfire, CDOCS, and process monitoring platforms.
Similar Job Opportunities
Skills, education and keywords
Skills: Root Cause Analysis, Fishbone, 5 WHYS, Kepner-Tregoe, Six Boxes, Lean Manufacturing, GMP, GDP, Trackwise, Spotfire.
Education: Bachelor's Degree in Engineering with 4+ years of experience; Master's Degree with 2+ years of experience; Doctorate Degree.
Frequently asked questions about Senior Engineer (3606404) at ProQuality Network
What does a Senior Engineer (3606404) at ProQuality Network do?expand_more
A Senior Engineer (3606404) at ProQuality Network is responsible for the following: Own and manage change controls related to manufacturing process changes; Lead deviation investigations including root cause analysis and CAPA; Design, coordinate, and execute functional tests and process challenge runs; and Generate and execute technical protocols and engineering documentation.
What are the requirements for this Senior Engineer (3606404) role?expand_more
To qualify for the Senior Engineer (3606404) at ProQuality Network position, applicants should have: Bachelor's Degree in Engineering with 4+ years experience OR Master's Degree with 2+ years experience OR Doctorate Degree; Open to Puerto Rico Residents; and Effective communication in English and Spanish.
Where is the Senior Engineer (3606404) role at ProQuality Network located?expand_more
Senior Engineer (3606404) at ProQuality Network is based in Hybrid. This is a hybrid role.
Is this Senior Engineer (3606404) job remote, hybrid, or on-site?expand_more
ProQuality Network has listed this Senior Engineer (3606404) role as hybrid.
How much experience is required for this Senior Engineer (3606404) role?expand_more
Senior Engineer (3606404) at ProQuality Network typically requires 2+ years of relevant experience at the senior level.
What skills do you need for the Senior Engineer (3606404) role at ProQuality Network?expand_more
Key skills for Senior Engineer (3606404) at ProQuality Network include Root Cause Analysis; Fishbone; 5 WHYS; Kepner-Tregoe; Six Boxes; Lean Manufacturing; GMP; and GDP.
What education is required for Senior Engineer (3606404) at ProQuality Network?expand_more
Educational requirements for this role: Bachelor's Degree in Engineering with 4+ years of experience; Master's Degree with 2+ years of experience; and Doctorate Degree.
What category does the Senior Engineer (3606404) role belong to?expand_more
Senior Engineer (3606404) at ProQuality Network is part of the engineering job category on Recrutus.