Descripción de la oferta
Efor is a leading pharmaceutical and biopharmaceutical consulting company committed to providing innovative solutions to the challenges facing our industries. We pride ourselves on our dedication to quality, safety, and excellence in everything we do. As we continue to grow, we are looking for a highly qualified and motivated PI ENGINEER to join our team.
Fluency in Spanish is mandatory
Position Title: PI Engineer
Location: Madrid
Type of Contract: Full-Time
Position Summary
A PI Engineer works at the intersection of engineering, quality, and operations. Their core mission is to ensure that drug manufacturing processes run smoothly, consistently, and efficiently.
Key Responsibilities
Monitor key process indicators (KPIs) and equipment performance metrics to ensure stable, predictable operations.
Use digital tools, data historians, and statistical software to evaluate process behavior and propose corrective actions.
Develop dashboards and reporting mechanisms to support decision‑making in manufacturing and engineering teams.
Ensure all process improvements comply with GMP, GAMP 5, and Pfizer quality standards.
Prepare and maintain technical documentation, including change controls, deviation investigations, CAPAs, and risk assessments.
Support audit readiness by ensuring processes and documentation meet regulatory expectations.
Work closely with Manufacturing, Quality Assurance, Automation, Validation, and Maintenance teams to implement process changes.
Provide technical support during batch execution, troubleshooting, and equipment interventions.
Participate in technology transfer activities for new products or processes entering the site.
Support validation activities (IQ/OQ/PQ) related to process changes, equipment upgrades, or recipe modifications.
Develop and execute test plans to verify process performance and ensure compliance with regulatory requirements.
Assist in the introduction of new equipment or technologies, ensuring seamless integration into existing workflows.
Review and refine equipment recipes, control strategies, and operating sequences to improve consistency and reduce variability.
Collaborate with automation engineers to align process improvements with digital systems (MES, SCADA, PLC).
Ensure equipment operates within validated parameters and supports high‑quality batch execution.
Education and Background
Bachelors degree in Chemical Engineering, Industrial Engineering, Pharmaceutical Engineering, or a related technical field.
Experience working in a GMP‑regulated manufacturing environment, ideally within the pharmaceutical or biotech industry.
Strong understanding of process engineering principles, including process mapping, capability analysis, and equipment performance evaluation.
Knowledge of Lean, Six Sigma, or continuous improvement methodologies, with the ability to apply statistical tools to real manufacturing problems.
Familiarity with validation and qualification activities (IQ/OQ/PQ) and change control processes.
Ability to interpret P&IDs, technical drawings, URS/FS/DS documents, and equipment manuals.
Proficiency in data analysis tools (Excel, Minitab, JMP, or similar) for trend analysis and root‑cause investigations.
Strong communication skills for cross‑functional work with Manufacturing, QA, Automation, and Maintenance teams.
Fluent English, with Spanish required when operating in Spanish‑speaking sites or teams.
What We Offer
Competitive salary.
Opportunities for professional development and training.
Dynamic and collaborative work environment.
Contribution to high-impact pharmaceutical projects.
Join Us
We encourage you to apply. PharmEng / Efor offers a dynamic and inclusive work environment, competitive compensation, and opportunities for professional growth. Be part of our team and contribute to the success of our industry-leading solutions.
PharmEng / Efor is an equal opportunity employer and welcomes applicants from all backgrounds.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the high volume of applications we receive, only approved candidates will be contacted.
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