Project Manager

Flexible & Integrated Technical Services, LLC•Dorado, PR

1d•Onsite

About The Position

The company is a Service Provider specializing in Engineering, Construction, Maintenance, Utilities, and Specialized Technical services for Pharmaceutical, medical device, and Manufacturing industries across the Island and in the US. They pride themselves on their flexible, family-oriented culture, and focus on the well-being of their employees, clients, and team members. The Project Manager role involves leading project management services, defining project goals, managing large, multi-project, multi-site cross-functional teams, overseeing Value Improvement (VIP) initiatives, and ensuring compliance with quality systems and regulatory expectations throughout the project lifecycle. The ideal candidate is a customer service professional, innovative, and committed to delivering top-quality results.

Requirements

Bachelor’s Degree in Engineering or Science.
Five - Seven (5–7) years of experience in manufacturing engineering or quality engineering within an FDA-regulated industry.
Bilingual: Spanish and English.
Attention to detail, organization, and writing skills.
Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good Manufacturing Practices (GMP), and ISO 13485.
Experience supporting new product introductions (NPI/NPD), including process development, equipment qualification, and process validation.
Hands-on experience with risk management (FMEA, hazard analysis), root cause investigations, and CAPA systems.
Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.
Familiarity with controlled documentation systems, engineering change processes, and manufacturing readiness requirements.
Experience ensuring compliance with quality system procedures and regulatory expectations across the project lifecycle.

Responsibilities

Define project goals, scope, resource and cost estimates, timeline, and risks.
Facilitate cross-functional discussions to develop project proposals.
Manage large, multi-project, multi-site cross-functional teams.
Provide performance input and foster strong alignment within teams.
Oversee VIP initiatives; identify, communicate, and manage risks.
Lead initiation, planning, execution, control, and closeout activities for projects/programs.
Ensure team ownership of plans, schedules, and budgets.
Ensure activities follow established processes.
Maintain documentation discipline.
Reinforce VIP and NPE best practices.
Drive cross-functional communication.
Serve as liaison between teams and leadership.
Lead phase reviews.
Maintain documentation including minutes, issue logs, and metrics.
Implement NPE methods; manage NPE risks and deliverables.