Project Engineer - Solid Dosage Mfg & Packaging (Pharma)

Job Description

Job Description

LOCATION: On Site – Pharmaceutical Manufacturing Site, Puerto Rico (Juncos/ Gurabo/ Las Piedras)

We are seeking a Project Engineer with a strong background in manufacturing and packaging projects within the pharmaceutical industry. The Project Engineer will lead and coordinate capital and facility improvement projects in manufacturing and packaging areas, including new equipment installation, line upgrades, layout changes, serialization/aggregation projects, and optimization initiatives.

This is a 100% on-site role, working closely with Manufacturing, Engineering, Maintenance, Quality, EHS and external vendors to ensure projects are planned and executed safely, on time, within budget, and in full compliance with cGMP and site procedures. The position is targeted to a mid-level engineer with solid technical and project coordination skills.

This is a contract-based opportunity for an independent professional willing to work at client site.

Main Responsibilities:

• Project & Technical Leadership
• Lead and oversee engineering projects in solid dosage manufacturing and secondary packaging (e.g., blister, bottle, cartoner, case packer, palletizer, serialization).
• Develop project scope, user requirements, and technical specifications for new or modified equipment and systems.
• Coordinate the full project lifecycle: concept, design, procurement, installation, commissioning, qualification and handover.
• Support and/or lead FAT, SAT, IQ/OQ/PQ activities in collaboration with Validation and Quality.
• Planning, Schedule & Cost Control
• Prepare and maintain detailed project schedules, milestones and look-ahead plans.
• Develop cost estimates, support capital requests, and track project budgets and financial close-out.
• Identify risks, constraints and impacts to production; propose mitigation plans to avoid or minimize downtime.
• Manufacturing & Packaging Interface
• Coordinate closely with Manufacturing and Packaging Operations to plan interventions without impacting supply or regulatory commitments.
• Support engineering studies to improve OEE, line throughput, changeover times, and scrap reduction in dosage and packaging lines.
• Participate in troubleshooting activities related to equipment performance, process robustness, and recurrent deviations.
• Compliance, EHS & Quality
• Ensure all work complies with cGMP, FDA, corporate engineering standards and the site Quality Management System (QMS).
• Coordinate with EHS to integrate safety requirements (LOTO, machine guarding, confined space, hot work, etc.) in project planning and execution.
• Prepare and maintain technical documentation, change controls, deviations, CAPAs, and engineering reports as required.
• Stakeholder Communication
• Provide regular status updates, dashboards and progress reports to management and key stakeholders.
• Facilitate project meetings with internal teams and external vendors/contractors.
• Promote best practices and continuous improvement in project execution and engineering standards.

General Requirements

• Bilingual (Spanish and English) – written and spoken.
• Proficiency in Microsoft Office 365 (Excel, Word, PowerPoint); experience with MS Project or similar scheduling tools preferred.
• Strong communication, presentation, and stakeholder-management skills.
• Availability to work on site and to adjust schedule (extended hours/weekends) during critical projector shutdown windows.

Education Requirements

• Bachelor’s degree in Engineering (Chemical, Mechanical, Industrial, Electrical or related discipline) is required.

Experience Requirements

• Minimum 3–6 years of experience as a Project Engineer, Process Engineer or similar role in the pharmaceutical or medical devices industry.
• At least 2 years of hands-on experience with solid oral dosage and/or secondary packaging lines (equipment installation, upgrades, optimization or tech transfer).
• Demonstrated experience managing small to medium capital projects (e.g., new equipment, line modifications, utilities interfaces, layout changes).
• Experience working under cGMP and Quality Management Systems (QMS); familiarity with FDA and/or EU requirements.
• Experience coordinating with manufacturing operations to plan and execute work without impacting production or quality.

Preferred

• Project Management certification (e.g., PMP or equivalent) is a plus.

Key Skills

• Strong analytical and problem-solving skills; ability to make sound technical decisions under time pressure.
• Ability to manage multiple projects simultaneously and prioritize effectively.
• High level of organization, attention to detail and safety-focused mindset.
• Excellent interpersonal skills to work with multidisciplinary internal teams and external vendors.