Job Description

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Validation Process Project Manager

Responsibilities:

• Owner's Representative Duties: Act as the owner's representative, ensuring that the project aligns with the owner's vision and requirements. Lead and manage manufacturing capital project to safely achieve project objectives from conceptual design through operational verification (cradle to grave cycle).
• Focus on Electrical Infrastructure and Distribution Management: Supervise the construction of the building's electrical systems, ensuring compliance with all relevant codes and regulations.
• Manage and oversee the construction of the pharmaceutical manufacturing facility, ensuring that all aspects of the project are completed on time, within budget, and to the highest quality standards.
• Change Order Management: Provide feedback and comments on change orders, ensuring that any modifications are necessary, cost-effective, and do not compromise the project's integrity.
• Deliver projects by managing project scope, schedule and budget while identifying and mitigating risks, all while prioritizing Safety First and Quality Always.
• Lead with a disciplined, structured approach to project management based on compliance with Company Policies and Procedures.
• Safety/Environment: Develop and maintain safety and environmental execution plans for projects. Ensure compliance to safety and environmental policies, procedures, and work rules for project personnel, contractors, and subcontractors from conceptual design through operational verification. Be an active member of the site safety team.
• Interface/Communication: Develop and maintain effective communication with the project team, governance teams, business partners and other stakeholders, as the size of the project may dictate. Facilitate issue resolution, anticipate scope changes, and implement safely with quality, speed, and value.
• Reviewing project plans and specifications.
• Monitoring contractor performance and ensuring adherence to contractual obligations.
• Conducting regular site walkdowns to review quality and progress.
• Ensuring compliance with safety regulations and quality standards.
• Develop detailed project plans, including scope, goals, deliverables, resource allocation, timelines, and budgets.
• Work closely with project managers, engineers, and stakeholders to ensure all aspects of the project are aligned and progressing smoothly.
• Provide engineering expertise and technical guidance throughout the project lifecycle.
• Maintain documentation of project activities, plans, designs, reports, and updates.
• Monitor project costs, manage budgets, and report on financial status.
• Identify potential risks and develop mitigation strategies to ensure project success.
• Ensure all project activities meet or exceed industry standards, regulations, and company quality guidelines.
• Regularly update stakeholders on project progress, challenges, and changes in scope.
• Address technical issues and project challenges, providing solutions to keep the project on track.

Qualifications:

• Bachelor's Degree in Engineering or Science.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in direct process / manufacturing areas.
• Must be fully bilingual (English / Spanish) with excellent oral skills.
• Must be proficient using MS Windows and Microsoft Office applications.
• Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.