Biotech Csv Jobs in Puerto Rico (NOW HIRING)

Location: Manatí & Barceloneta, Puerto Rico (On Site)

Industry: Pharmaceutical Manufacturing

Position Type: Contract

General Job Description

The Project Manager will be responsible for leading and coordinating Capital Projects, Automation, Utilities, Infrastructure, and Commissioning & Qualification (C&Q) projects within pharmaceutical manufacturing environments. This role oversees project planning, execution, timelines, resource allocation, and stakeholder communication while ensuring compliance with GMP regulations and industry standards. The Project Manager will work cross-functionally with Engineering, Automation, Validation, Quality, Manufacturing, Facilities, Utilities, Construction teams, and external vendors to ensure successful project delivery.

Job Overview

We are seeking a motivated and detail-oriented Project Manager with experience supporting pharmaceutical capital projects, automation initiatives, utility systems, infrastructure improvements, and Commissioning & Qualification (C&Q) activities. The ideal candidate will possess strong leadership, communication, and organizational skills and be capable of managing multiple projects while ensuring compliance with regulatory and quality standards. This individual will play a key role in driving project execution from initiation through completion.

Main Responsibilities

• Lead and manage pharmaceutical capital, automation, utilities, infrastructure, and C&Q projects from planning through completion.

• Develop project schedules, timelines, budgets, and resource plans.

• Coordinate cross-functional teams including Engineering, Automation, Validation, Quality, Manufacturing, Facilities, Utilities, Construction, and external vendors.

• Monitor project progress and ensure milestones and deliverables are met.

• Identify project risks and develop mitigation strategies.

• Track project scope and manage changes effectively.

• Ensure compliance with GMP, FDA, and industry regulatory requirements.

• Support commissioning, qualification, validation, and startup activities for systems, equipment, facilities, and utilities.

• Manage projects involving automation systems, process control systems, utilities, facility infrastructure upgrades, and sterile manufacturing support systems.

• Facilitate project meetings and provide status updates to stakeholders and leadership.

• Maintain project documentation and ensure proper record management.

• Support continuous improvement initiatives and project execution strategies.

General Requirements

• Strong understanding of pharmaceutical manufacturing environments.

• Knowledge of Commissioning & Qualification (C&Q) lifecycle activities.

• Familiarity with GMP regulations and quality standards.

• Experience supporting capital projects, automation systems, utility systems, facility infrastructure projects, or construction activities within regulated environments.

• Knowledge of automation platforms, process control systems, Computer Systems Validation (CSV), or related technologies is preferred.

• Strong project planning and organizational skills.

• Excellent communication and stakeholder management abilities.

• Ability to prioritize multiple tasks and manage competing deadlines.

• Proficiency in Microsoft Office Suite and project management tools.

• Ability to work independently and in a team-oriented environment.

• Strong problem-solving and analytical skills.

Education

• Bachelor’s degree in Engineering, Life Sciences, Pharmaceutical Sciences, Project Management, Construction Management, or related technical field.

• Project Management certifications (PMP or similar) are a plus.

Experience

• Minimum of 3 years of experience in Project Management within pharmaceutical, biotech, medical device, or regulated manufacturing environments.

• Experience supporting Capital Projects, Automation Projects, Utilities Systems, Infrastructure Projects, Construction Projects, or Commissioning & Qualification (C&Q) activities preferred.

• Experience managing cross-functional teams and project deliverables.

• Experience working with sterile manufacturing environments, process control systems, automation platforms, utilities, or facility infrastructure projects is highly desirable.

• Knowledge of pharmaceutical processes and regulatory environments preferred.

Physical Requirements

• Ability to work in office, manufacturing, laboratory, utility, and production environments.

• Ability to stand, walk, sit, and move throughout facilities for extended periods.

• May require occasional lifting of up to 20 lbs.

• Ability to wear required Personal Protective Equipment (PPE) in manufacturing areas.

• May require occasional travel to client sites or project locations.

• Ability to access controlled manufacturing, utility, construction, and cleanroom environments as needed.