Project Manager

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:

Project Manager

Job Summary:

Provide vision and leadership to strategic projects with significant site impact. Ensure new

products are launched from the site in alignment with contract goals. Manage the

performance of projects or significant subsystems associated with new products by

influencing, coordinating, and driving activities, initiatives, and development deliverables

across cross-functional teams. Direct all phases of new product development projects from

inception through completion from an Operations perspective. Lead project review sessions

focusing on cost, schedule, and technical performance. Establish milestones, monitor

adherence to plans and schedules, identify issues, and implement solutions. Demonstrate

strong leadership, clear communication, and the ability to build effective cross-functional

working relationships. Ensure Value Improvement Projects (VIP) and new product

initiatives are completed in alignment with contract expectations.

Key Responsibilities:

Project Planning & Definition: Define project goals, scope, resource and cost estimates,

timeline, and risks. Facilitate cross-functional discussions to develop project proposals.

• People Leadership: Manage large, multi-project, multi-site cross-functional teams;

provide performance input; foster strong alignment.

• Value Improvement (VIP): Oversee VIP initiatives; identify, communicate, and manage

risks.

• Project / Program Management: Lead initiation, planning, execution, control, and closeout activities; ensure team ownership of plans, schedules, and budgets.

• Process Management: Ensure activities follow established processes; maintain

documentation discipline; reinforce VIP and NPE best practices.

• Communications & Reviews: Drive cross-functional communication; serve as liaison

between teams and leadership; lead phase reviews; maintain documentation including

minutes, issue logs, and metrics.

• New Product Excellence (NPE): Implement NPE methods; manage NPE risks and

deliverables.

Qualifications:

5–7+ years of experience in manufacturing engineering or quality engineering within an

FDA-regulated industry (medical devices, pharmaceuticals, biotechnology, diagnostics,

or similar).

• Strong knowledge of FDA Quality System Regulation (21 CFR Part 820), Good

Manufacturing Practices (GMP), and ISO 13485.

• Experience supporting new product introductions (NPI/NPD), including process

development, equipment qualification, and process validation.

• Hands-on experience with risk management (FMEA, hazard analysis), root cause

investigations, and CAPA systems.

• Proven collaboration with Operations, Quality Assurance, Regulatory, R&D, and Supply

Chain teams.

• Familiarity with controlled documentation systems, engineering change processes, and

manufacturing readiness requirements.

• Experience ensuring compliance with quality system procedures and regulatory

expectations across the project lifecycle

Quality System Requirements:

Demonstrate a primary commitment to patient safety and product quality by adhering to

applicable quality policies, procedures, and requirements.

For roles with direct reports: Ensure adequate resources (personnel, tools, etc.) are in place

to support quality compliance and promote a work environment aligned with quality

expectations.

Job Scope & Leveling Guidelines:

• Functional Knowledge: Applies in-depth conceptual, practical, and technical knowledge;

understands related functions.

• Business Expertise: Applies knowledge of key business drivers and cross-team

integration to achieve objectives.

• Leadership: Provides guidance, coaching, and may lead smaller projects or sub-projects

with manageable risk.

• Problem Solving: Solves problems of varying complexity; adapts or develops solutions

using judgment and experience.

• Impact: Influences project, operational, or service activity effectiveness.

• Interactions: Communicates complex information clearly; persuades and guides

stakeholders in cross-functional settings.

Full-time