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:

• Project Manager

Job Summary:
The Project Manager will provide vision and leadership to strategic projects with significant site impact, ensuring new products are launched in alignment with contract goals. They will lead project review sessions, establish milestones, monitor adherence to plans, and implement solutions. Strong leadership, clear communication, and effective cross-functional relationship-building are essential.

Key Responsibilities:

• Define project goals, scope, resource/cost estimates, timeline, and risks.
• Manage large cross-functional teams, provide performance input, and foster alignment.
• Oversee Value Improvement (VIP) initiatives and manage risks.
• Lead initiation, planning, execution, control, and close-out activities.
• Maintain process documentation discipline and reinforce best practices.
• Drive cross-functional communication, lead phase reviews, and maintain documentation.
• Implement New Product Excellence (NPE) methods and manage deliverables.

Qualifications:

• 5-7+ years of experience in manufacturing or quality engineering in FDA-regulated industries.
• Strong knowledge of FDA Quality System Regulation, Good Manufacturing Practices, and ISO 13485.
• Experience with new product introductions, risk management, and root cause investigations.
• Collaboration experience across Operations, Quality Assurance, Regulatory, R&D, and Supply Chain teams.
• Familiarity with controlled documentation systems and compliance with quality system procedures.

Quality System Requirements:
Demonstrate dedication to patient safety and product quality by adhering to quality policies, procedures, and requirements. Ensure adequate resources are in place to support quality compliance and maintain a quality-focused work environment.

Job Scope & Leveling Guidelines:
Applies in-depth knowledge across functions; understands key business drivers.
Provides guidance, coaching, and leads projects with manageable risk.
Uses judgment and experience to solve problems and influence operational effectiveness.
Communicates complex information clearly and guides stakeholders.

Additional Information:
The responsibilities outlined are not exhaustive. Training requirements are established and tracked through individual learning plans. Physical requirements should be consulted with the local Environmental Health & Safety (EHS) team. Support a work environment aligned with EHS and Energy Policies.