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Senior Investigations Engineer
North Area, PR · Biotech/PharmaceuticalPosition Purpose
Serve as the site’s technical authority for complex investigations—deviations, equipment failures, OOS/OOT results, and systemic quality events—at a high‑volume pharmaceutical plant in North of Puerto Rico. Your charge: find the real root cause, design unbreakable CAPAs, and return operations to cGMP compliance with speed and precision so patients never feel a disruption.
Key Responsibilities
Lead cross‑functional investigations across Manufacturing, QC, Utilities, and Engineering using structured RCA tools (5 Whys, Ishikawa, FMEA, statistical DOE).
Author and close investigation reports, change controls, and CAPAs that stand up to regulator scrutiny—on or ahead of schedule.
Design, implement, and verify CAPAs in partnership with QA, MS&T, Maintenance, and Validation to drive sustainable reliability improvements.
Walk the floor (GEMBA), interview operators, gather real‑time data, and validate hypotheses to ground every conclusion in process reality.
Defend complex cases during internal audits and health‑authority inspections, safeguarding the site’s license to operate.
Mentor junior engineers on RCA methodology and foster a “right‑first‑time” culture to multiply technical capability across the plant.
Must‑Have Qualifications
B.S. in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related). M.S. preferred.
5 -8+ years leading deviation/CAPA investigations under FDA 21 CFR 210/211 or EU GMP in pharma, biotech, or medical‑device manufacturing.
Proven mastery of RCA tools and statistical software (Minitab, JMP, etc.).
Fluent English & Spanish technical writing and presentation skills.
Availability for off‑shift call‑outs; manufacturing never sleeps.
Nice‑to‑Have Extras
Lean Six Sigma Green/Black Belt certification.
Experience with TrackWise, Veeva Vault, or similar eQMS platforms.
Prior exposure to oral‑solid‑dose or sterile fill‑finish operations.
Reliability engineering / ISO 14971 risk‑management expertise.
Core Competencies
Forensic problem‑solver with systems thinking.
Persuasive communicator who can translate statistics into plain‑English action.
Collaborative leader who influences across Manufacturing, Quality, and MS&T.
Relentless focus on compliance, efficiency, and continuous improvement.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*
Serve as the site’s technical authority for complex investigations—deviations, equipment failures, OOS/OOT results, and systemic quality events—at a high‑volume pharmaceutical plant in North of Puerto Rico. Your charge: find the real root cause, design unbreakable CAPAs, and return operations to cGMP compliance with speed and precision so patients never feel a disruption.
Key Responsibilities
Lead cross‑functional investigations across Manufacturing, QC, Utilities, and Engineering using structured RCA tools (5 Whys, Ishikawa, FMEA, statistical DOE).
Author and close investigation reports, change controls, and CAPAs that stand up to regulator scrutiny—on or ahead of schedule.
Design, implement, and verify CAPAs in partnership with QA, MS&T, Maintenance, and Validation to drive sustainable reliability improvements.
Walk the floor (GEMBA), interview operators, gather real‑time data, and validate hypotheses to ground every conclusion in process reality.
Defend complex cases during internal audits and health‑authority inspections, safeguarding the site’s license to operate.
Mentor junior engineers on RCA methodology and foster a “right‑first‑time” culture to multiply technical capability across the plant.
Must‑Have Qualifications
B.S. in Engineering (Mechanical, Chemical, Industrial, Biomedical, or related). M.S. preferred.
5 -8+ years leading deviation/CAPA investigations under FDA 21 CFR 210/211 or EU GMP in pharma, biotech, or medical‑device manufacturing.
Proven mastery of RCA tools and statistical software (Minitab, JMP, etc.).
Fluent English & Spanish technical writing and presentation skills.
Availability for off‑shift call‑outs; manufacturing never sleeps.
Nice‑to‑Have Extras
Lean Six Sigma Green/Black Belt certification.
Experience with TrackWise, Veeva Vault, or similar eQMS platforms.
Prior exposure to oral‑solid‑dose or sterile fill‑finish operations.
Reliability engineering / ISO 14971 risk‑management expertise.
Core Competencies
Forensic problem‑solver with systems thinking.
Persuasive communicator who can translate statistics into plain‑English action.
Collaborative leader who influences across Manufacturing, Quality, and MS&T.
Relentless focus on compliance, efficiency, and continuous improvement.
**Weil Group is proud to be an Equal Employment Opportunity Employer.*