Job Board for Professionals in Puerto Rico

Job Summary

The Project Engineer in this role will assist in the planning, coordination, and execution of projects within the pharmaceutical industry. This position focuses on providing essential support to senior project managers by managing project schedules, coordinating cross-functional teams, and ensuring that project tasks are completed on time. The role is critical in maintaining project documentation, facilitating communication, and ensuring that project objectives align with organizational goals and regulatory standards.

Key Responsibilities

• Manage, organize the resources on projects.
• Identify changes in schedules, materials, work out of scope or other details in the project and manage change orders with clients.
• Coordinate projects execution, schedule and lead meetings with resources and representatives to gain cross functional understanding and consensus on project content and execution.
• Manage and control the project documentation in collaboration with all teams.
• Implementation and enforcement of client requirements with all documentation appropriate to comply with all regulatory standards.
• This role will take on responsibility for the project elements for all systems by updating project plans, reviewing all project deliverables, reviewing testing coverage to ensure adequacy, performing system and supplier assessments, managing the change control process, and conducting risk analysis to drive and implement process improvements as required.
• The role holder will need to influence, engage, and develop leaders in leading project compliance, and ensure that technology is used to support an effective and efficient approach to project to minimize business disruption.
• Lead and/or coordinate investigations into failures to meet acceptance criteria and determine and implement appropriate resolutions.
• Manage all project aspects as part of project work, or act as lead or mentor for specific project resources.
• Manage formal testing of computerized systems including identifying and implementing tools, setup of testing, documentation, approval, and delivery.
• Work directly with personnel at several levels execute strategies in a project (project leaders, account managers, contractors, employees, vendors, etc.)
• Responsible for the support on projects or multiple tasks within functional disciplines.
• Provide, coordinate engineer support for projects in control systems, troubleshooting, maintenance, CSV, IT.
• In charge and report project status, information, and communications.
• Communicate, answer client queries or concerns about projects, resources, and related matters.
• Communicate the project progress of daily/weekly/monthly/quarterly initiatives.
• Maintain up to date knowledge of evolving regulatory requirements, availability of current/new techniques, and literature regarding compliant computer operations, and act as an information resource for the team and wider business.

Education

• Bachelor's degree in Engineering, Sciences, or a related field.

Experience

• A minimum of 2 years of experience in project management, preferably within the pharmaceutical, biotechnology, or related industries.
• Proven track record of successfully managing complex projects, with experience in the validation of electronic Quality Management Systems (eQMS) or similar systems.
• Exceptional organizational skills, with a proactive and self-motivated approach. Able to work independently with minimal direction, demonstrating significant autonomy in setting objectives, selecting appropriate methods for new assignments, and effectively managing multiple projects and deadlines. Ensures strict compliance with global CSV processes.
• Relies on limited experience and judgment to plan and accomplish goals.
• Knowledge of commonly used concepts, practices, and procedures in federal and state regulations.
• Ability to effectively manage and resolve complex, cross-functional challenges by applying technical expertise, creative problem-solving, and innovative thinking.
• Experienced in providing guidance and support to company personnel, contractors, and other resources, fostering collaboration and ensuring successful project outcomes.
• Experience of involvement in regulatory inspections and audits, able to guide as a backup contact for the CSV validation program for inspectors during inspections and audits.
• Proficiency in computer programs: Microsoft Office (Word, Excel).
• Fluency in English and Spanish languages (written/spoken).
• Strong background in Automation and Computer Systems Validation (CSV), with a deep understanding of industry best practices.
• Good understanding of business requirements, high-level solutions, and infrastructure components, combined with CSV system experience.
• Preferably experienced in project definition and initiation, particularly related to automation and CSV.
• Knowledge of business processes and the ability to drive meaningful changes within an organization.
• Skilled at fostering win-win solutions among diverse stakeholders, ensuring alignment and collaboration.
• Preferably experienced in change management, including stakeholder management, communication strategies, planning, knowledge management, and training.

Other Requirements

• Sitting: Frequently
• Standing/ Walking: Frequently
• Lift/ Carry over: Not to exceed 20 lbs.
• Repetitive motions: Typing on keyboard - Frequently.
• Visual Demand: Extended periods of focusing on a computer screen.
• Work Schedule: Require flexible time, including the capacity to work overtime, different schedules, and holidays or weekends as needed, to meet shutdown demands.
• Travel Requirements: Availability to work and travel within the United States.

Equal Opportunity Statement:

Synerlution is committed to providing equal employment opportunities for all employees and applicants, regardless of race, color, religion, gender, sexual orientation, national origin, age, disability, genetic information, marital status, or veteran status. We feel that having a diverse staff increases our capacity to drive synergy through solutions for our clients. We are committed to fostering an inclusive environment in which all employees feel comfortable sharing their unique ideas and talents.

Synerlution strictly condemns all forms of discrimination and harassment and provides a respectful, supportive, and bias-free workplace. We value all forms of diversity and are dedicated to offering equal opportunities for employees to advance and grow professionally.