Job Description

Validation & Engineering Group, Inc. (V&EG) 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: * Project Manager Operations Readiness We are seeking an experienced and dynamic Project Manager for Operations Readiness to join our biotech team. This role ensures the seamless integration of operational processes, systems, and resources as we transition from project execution to operational excellence. The Project Manager will lead cross-functional teams to drive readiness efforts, ensuring the organization is equipped to deliver on its strategic objectives while maintaining compliance with regulatory standards. Key Responsibilities: 1. Operations Readiness Planning:

• Develop and implement a comprehensive operations readiness plan to support facility start-up, production launches, or scale-up projects.
• Coordinate activities between engineering, manufacturing, quality, supply chain, and other functional teams to ensure readiness milestones are achieved.

2. Project Management:

• Define project scope, objectives, deliverables, and timelines aligned with organizational goals.
• Manage project budgets, resource allocations, risks, and progress reports.
• Use project management tools and methodologies to monitor project performance and ensure timely execution.

3. Stakeholder Collaboration:

• Facilitate collaboration among cross-functional teams, vendors, and contractors to align efforts and ensure operational goals are met.
• Act as the central point of communication for project updates, ensuring all stakeholders are informed and aligned.

4. Risk Management and Compliance:

• Identify potential risks, develop mitigation strategies, and ensure project plans comply with regulatory standards (e.g., FDA, EMA, GMP).
• Ensure quality assurance processes are integrated into all operations readiness activities.

5. Change Management:

• Lead organizational change initiatives associated with new processes, technologies, or systems.
• Develop training plans to prepare teams for operational transitions.

6. Performance Metrics and Continuous Improvement:

• Define and track key performance indicators (KPIs) to measure the success of operational readiness initiatives.
• Identify opportunities for continuous improvement in operational efficiency and scalability.

Qualifications: * Education: Bachelors degree in engineering, life sciences, business administration, or a related field. Advanced degree (MBA or MS) preferred. Experience:

• 5+ years of project management experience in the biotech, pharmaceutical, or life sciences industry.
• Proven track record of leading complex, cross-functional projects, preferably in operations readiness or facility start-up.

Skills:

• Proficiency in project management tools (e.g., MS Project, Smartsheet).
• Strong knowledge of GMP, FDA, EMA, and other regulatory requirements.
• Excellent communication, leadership, and problem-solving skills.
• Ability to manage multiple projects simultaneously in a fast-paced environment.
• Lean Six Sigma or PMP certification is a plus.

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